Documento Ginecologia

Laparoscopic entry techniques (Review)
Ahmad G, OFlynn H, Duffy JMN, Phillips K, Watson A

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library
2012, Issue 2
http://www.thecochranelibrary.com
Laparoscopic entry techniques (Review)
Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
T A B L E O F C O N T E N T S
1 HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .
5 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
8 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
18 ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .
35 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
37 AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
37 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
37 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
40 CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
74 DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 1 Mortality. . . . . . 78
Analysis 1.2. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 2 Vascular injury. . . . 79
Analysis 1.3. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 3 Visceral (bladder or bowel)
injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
Analysis 1.6. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 6 Failed entry. . . . . 80
Analysis 1.7. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 7 Extraperitoneal insufation. 81
Analysis 1.8. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 8 Trocar site bleeding. . 82
Analysis 1.9. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 9 Infection. . . . . . 83
Analysis 1.10. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 10 Omentum injury. . 84
Analysis 2.1. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 1 Mortality. . . . . . . . 84
Analysis 2.2. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 2 Vascular injury. . . . . . 85
Analysis 2.3. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 3 Visceral (bladder or bowel) injury. 86
Analysis 2.4. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 4 Gas embolism. . . . . . 86
Analysis 2.5. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 5 Solid organ injury. . . . . 87
Analysis 2.6. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 6 Failed entry. . . . . . . 87
Analysis 2.7. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 7 Extraperitoneal insufation. . 88
Analysis 2.9. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 9 Infection. . . . . . . . 89
Analysis 2.10. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 10 Omentum injury. . . . 89
Analysis 3.3. Comparison 3 Direct-vision entry versus Veress Needle entry, Outcome 3 Visceral (bladder or bowel) injury. 90
Analysis 3.8. Comparison 3 Direct-vision entry versus Veress Needle entry, Outcome 8 Trocar site bleeding. . . . 90
Analysis 4.5. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 5 Solid organ injury. . . . 91
Analysis 4.6. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 6 Failed entry. . . . . . 91
Analysis 4.8. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 8 Trocar site bleeding. . . . 92
Analysis 6.2. Comparison 6 Radially expanding (STEP) trocars versus standard trocars (primary port entry), Outcome 2
Vascular injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
Visceral (bladder or bowel) injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
Solid organ injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94
Trocar site bleeding. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95
Analysis 9.1. Comparison 9 Comparisons of sites of entry, Outcome 1 Transfundal versus infra-umbilical insertion of the
Veress Needle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
i Laparoscopic entry techniques (Review)
Analysis 10.1. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 1 Lifting versus not lifting
the abdominal wall before Veress Needle insertion. . . . . . . . . . . . . . . . . . . . . . 97
Analysis 10.2. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 2 Carbon dioxide gas
insufation versus gasless abdominal wall retractor. . . . . . . . . . . . . . . . . . . . . . 98
Analysis 10.3. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 3 A closed technique versus
a parallel technique of Veress Needle insertion. . . . . . . . . . . . . . . . . . . . . . . 99
Analysis 10.5. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 5 Cutting trocars versus
blunt trocars. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100
Analysis 10.7. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 7 5 mm versus 3 mm
secondary port trocars. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
Analysis 10.8. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 8 Radially expanding (STEP)
secondary trocars versus standard secondary trocars. . . . . . . . . . . . . . . . . . . . . . 102
102 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
110 WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
111 HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
111 CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
112 DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
112 SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
112 DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .
112 INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ii Laparoscopic entry techniques (Review)
[Intervention Review]
Laparoscopic entry techniques
Gaity Ahmad
1
, Helena OFlynn
2
, James MN Duffy
3
, Kevin Phillips
4
, Andrew Watson
5
1
Obstetrics & Gynaecology, Pennine Acute NHS Trust, Manchester, UK.
2
University Hospital of South Manchester, Manchester,
UK.
3
Department of Womens Health, Barts and the Royal London School of Medicine and Dentistry, London, UK.
4
Obstetrics and
Gynaecology, Castle Hill Hospital, Cottingham, UK.
5
Tameside & Glossop Acute Services NHS Trust, Tameside General Hospital,
Ashton-Under-Lyme, UK
Contact address: Gaity Ahmad, Obstetrics & Gynaecology, Pennine Acute NHS Trust, Manchester, UK. gaityahmad@hotmail.com.
gaityahmad@aol.com.
Editorial group: Cochrane Menstrual Disorders and Subfertility Group.
Publication status and date: Edited (conclusions changed), published in Issue 2, 2012.
Review content assessed as up-to-date: 1 April 2011.
Citation: Ahmad G, OFlynn H, Duffy JMN, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database of Systematic
Reviews 2012, Issue 2. Art. No.: CD006583. DOI: 10.1002/14651858.CD006583.pub3.
A B S T R A C T
Background
Laparoscopy is a common procedure in gynaecology. Complications associated with laparoscopy are often related to entry. Life-
threatening complications include injury to the bowel, bladder, major abdominal vessels, and an anterior abdominal-wall vessel. Other
less serious complications can also occur, such as post-operative infection, subcutaneous emphysema and extraperitoneal insufation.
There is no clear consensus as to the optimal method of entry into the peritoneal cavity. This is an update of a Cochrane review rst
published in 2008.
Objectives
To evaluate the benets and risks of different laparoscopic techniques in gynaecological and non-gynaecological surgery.
Search methods
This review has drawn on the search strategy developed by the Cochrane Menstrual Disorders and Subfertility Group. In addition,
MEDLINE, EMBASE, CENTRAL and PsycINFO were searched through to February 2011.
Selection criteria
Randomised controlled trials were included when one laparoscopic entry technique was compared with another.
Data collection and analysis
Data were extracted independently by the rst three authors. Differences of opinion were registered and resolved by the fourth author.
Results for each study were expressed as odds ratio (Peto OR) with 95% condence interval (CI).
Main results
The review included 28 randomised controlled trials with 4860 individuals undergoing laparoscopy and evaluated 14 comparisons.
Overall there was no evidence of advantage using any single technique in terms of preventing major vascular or visceral complications.
Using an open-entry technique compared to a Veress Needle demonstrated a reduction in the incidence of failed entry, Peto OR 0.12
(95% CI 0.02 to 0.92). There were three advantages with direct-trocar entry when compared with Veress Needle entry, in terms of
1 Laparoscopic entry techniques (Review)
lower rates of failed entry (Peto OR 0.21, 95% Cl 0.14 to 0.31), extraperitoneal insufation (Peto OR 0.18, 95% Cl 0.13 to 0.26),
and omental injury (Peto OR 0.28, 95% CI 0.14 to 0.55).
There was also an advantage with radially expanding access system (STEP) trocar entry when compared with standard trocar entry, in
terms of trocar site bleeding (Peto OR 0.31, 95% Cl 0.15 to 0.62). Finally, there was an advantage of not lifting the abdominal wall
before Veress Needle insertion when compared to lifting in terms of failed entry, without an increase in the complication rate (Peto
OR 4.44, 95% CI 2.16 to 9.13). However, studies were limited to small numbers, excluding many patients with previous abdominal
surgery and women with a raised body mass index who may have unusually high complication rates.
Authors conclusions
An open-entry technique is associated with a signicant reduction in failed entry when compared to a closed-entry technique, with no
difference in the incidence of visceral or vascular injury.
Signicant benets were noted with the use of a direct-entry technique when compared to the Veress Needle. The use of the Veress
Needle was associated with an increased incidence of failed entry, extraperitoneal insufation and omental injury; direct-trocar entry
is therefore a safer closed-entry technique.
The low rate of reported complications associated with laparoscopic entry and the small number of participants within the included
studies may account for the lack of signicant difference in terms of major vascular and visceral injury between entry techniques. Results
should be interpreted with caution for outcomes where only single studies were included.
P L A I N L A N G U A G E S U M M A R Y
Laparoscopic entry techniques
A laparoscope is a medical telescope that is inserted under general anaesthesia through small (0.5 to 1 cm) incisions in or near the
umbilicus in order to inspect the pelvis or abdomen. Laparoscopy enables direct visualisation of the pelvic and abdominal organs with
the laparoscope so key-hole surgery can be performed as indicated. To performlaparoscopy, gas is inserted into the abdomen. Although
usually safe, a small minority of patients experience life-threatening complications, including injuries to the blood vessels (0.9 per 1000
procedures) and the bowel (1.8 per 1000 procedures). These complications often occur at the rst step of the procedure when the
abdominal wall is perforated using specialised instruments to insert the gas. Different doctors use different specialised instruments and
techniques. The update of this review demonstrated a reduction in the incidence of failed entry with the use of an open-entry technique
in comparison to closed entry. A reduction in the incidence of failed entry, reduced risk of extraperitoneal insufation (gas in the layers
of the abdominal wall) and reduced omental injury were demonstrated with the use of a direct-entry technique in comparison to Veress
Needle entry. This review found no evidence that any single technique or specialised instrument used to enter the abdomen helped
to reduce the occurrence of vascular and organ injury. More research is required regarding safety, especially in newer techniques for
example single-incision laparoscopic surgery (SILS).
S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]
Open entry technique versus closed entry technique for women undergoing laparoscopy
Patient or population: patients with undergoing laparoscopy
Settings: Surgical
Intervention: Open entry technique
Comparison: Closed entry technique
Outcomes Illustrative comparative risks* (95% CI) Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed risk Corresponding risk
Closed entry technique Open entry technique
Major Complications -
Vascular injury
13 per 1000 2 per 1000
(0 to 84)
OR 0.14
(0 to 6.82)
150
(1 study)
very low
1,2,3
Visceral injury
13 per 1000 13 per 1000
(1 to 179)
OR 1
(0.06 to 16.14)
150
(1 study)
very low
1,3,4
Minor Complications -
Extraperitoneal insuffla-
tion
27 per 1000 10 per 1000
(1 to 68)
OR 0.36
(0.05 to 2.61)
220
(2 studies)
low
2,5
Trocar site bleeding
13 per 1000 2 per 1000
(0 to 84)
OR 0.14
(0 to 6.82)
150
(1 study)
very low
1,2,3
Trocar site infection
45 per 1000 54 per 1000
(17 to 161)
OR 1.21
(0.36 to 4.04)
220
(2 studies)
very low
4,5
Failure of entry
114 per 1000 15 per 1000
(3 to 106)
OR 0.12
(0.02 to 0.92)
70
(1 study)
low
3,6
Injury to mesentery
29 per 1000 4 per 1000
(0 to 167)
OR 0.14
(0 to 6.82)
70
(1 study)
very low
2,3,6
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*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the
assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.
1
Allocation concealment was not adequately explained and blinding was unclear
2
Summary effect crosses the line of no effect and appreciable benefit or harm
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Evidence is based on a single trial
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Summary effect crosses the line of no effect and appreciable benefit and harm
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Blinding was unclear in both studies
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Blinding and attrition information were unclear
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B A C K G R O U N D
There can be complications related to the method of entry of the
laparoscope (Jansen 2004). The most serious complications can
be life threatening and include bowel, major abdominal vessel and
anterior abdominal wall vessel perforation. Fortunately these most
serious complications are rare, with the incidence of bowel perfo-
ration reported as being 1.8 per 1000 cases, and the incidence of
major abdominal vessel and anterior abdominal wall vessel perfo-
ration reported as being 0.9 per 1000 cases (RCOG1978). Whilst
these low rates are heartening, it still implies that over 250 indi-
viduals in the United Kingdom will suffer a serious complication
each year (Middles Cons, 1999). As well as these very serious op-
erative complications, there are other less serious complications
such as post-operative infection, subcutaneous emphysema, and
extraperitoneal insufation (Copeland 1983; Sigman 1993).
Description of the condition
Laparoscopy is a very common procedure in gynaecology and is
increasingly used in other specialties. There is evidence that la-
paroscopy provides signicant benets compared with laparotomy
(a surgical procedure involving an incision through the abdominal
wall to gain access into the abdominal cavity, an open technique)
for patients and healthcare providers (Garry 1999). However, the
majority of complications associated with laparoscopy occur at the
time of entry. Opinion is divided as to the safest entry technique.
A closed method of entry is commonly used by gynaecologists,
however surgeons routinely use open methods of entry.
Description of the intervention
Many differing laparoscopic-entry methods have been described.
These include a closed technique, which has two variations. The
rst involves the insertion of a Veress Needle (a needle equipped
with a spring-loaded obturator) into the peritoneal cavity, followed
by gas insufation (act of blowing) then insertion of a trocar (a
sharp, pointed instrument with a cannula used to enter the body
cavity); nally the laparoscope is passed through the trocar once
the obturator is removed. The second involves the insertion of a
trocar directly into the peritoneal cavity, followed by laparoscopic
inspection and then gas insufation. The potential benets of the
direct entry are shorter operating times, immediate recognition
of bowel or vascular injuries and near exclusion of entry failure
(Copeland 1983). The alternative open technique involves the
peritoneum being cut down, followed by the insertion of a blunt
trocar under direct visualisation, gas insufation and insertion
of the laparoscope. The potential benets of this technique are
the prevention of vascular injury, gas embolism, pre-peritoneal
insufation and a low incidence of bowel injury (Sigman 1993).
However, direct entry may be anunder-utilised and safe alternative
to the Veress Needle and open-entry techniques (Molloy 2002).
Several other methods, including the radially expanding access sys-
tem (STEP) and single-incision laparoscopic surgery (SILS), have
also been described. STEP (Inner Dyne, Sunnyvale, California,
USA) was developed to minimise tissue trauma. This system uses
a pneumoperitoneum needle with a polymeric sleeve. Following
routine insufation the needle is removed, leaving the outer sleeve
in situ. Direct dilatation of the sleeve results in a port 12 mm in
size. The suggested benets are that only one sharp instrument
enters the abdominal cavity, less tissue trauma occurs and, in the-
ory, fewer bowel and vascular injuries occur (Ternamian 1997;
Ternamian 1998).
SILS (Covidien Plc , Dublin, Ireland) was designed with the
aim of reducing the invasiveness of entry into the peritoneal cav-
ity when compared to traditional laparoscopic entry techniques
(Tsimoyiannis 2009). This approach involves a single intra-um-
bilical 12 mm incision with the umbilicus being pulled out, ex-
posing the fascia. Pneumoperitoneum is induced with an atrau-
matic trocar introduced into the abdomen by an open technique.
Second and third trocars are introduced to the left and right of
the rst trocar, leaving a small bridge of fascia between them to
avoid leakage of carbon dioxide. The suggested benets include a
reduction in post-operative pain and an improved cosmetic result
(Tsimoyiannis 2009).
Several techniques for secondary port insertion have also been de-
scribed. Although secondary port insertion techniques have also
been investigated within the review, the majority of included stud-
ies investigated primary port entry techniques. As secondary ports
are inserted under direct vision, complication rates should be
lower.
How the intervention might work
Observational studies indicated that the incidence of vascular in-
jury was reduced with the use of open entry in comparison to
closed entry. It has been hypothesised that as the closed technique
involves blindly inserting trocars, anopentechnique may be a safer
option for entry (Molloy 2002).
Manufacturers have hypothesised that the use of direct vision
should reduce complication rates as the trocar is not inserted
blindly.
The space between the abdominal wall and intraperitoneal struc-
tures should be safer with higher pressures of gas, decreasing the
complication rate.
Why it is important to do this review
There is no clear consensus as to the optimal method of entry
into the peritoneal cavity (Merlin 2003; Molloy 2002). The Royal
College of Obstetricians and Gynaecologists (RCOG) produced a
national Green-top guideline in 2008 entitled Preventing entry-
related gynaecological laparoscopic injuries (RCOG 2008). The
document emphasised the need for an intra-umbilical incision,
sharp Veress Needle, at position of the patient, and pressure not
volume of gas to determine when to place the trocar in the peri-
toneal cavity. There is also a recommendation that all entry phases
of laparoscopy be performed with the patient lying level, with no
Trendelenburg tilt, because this patient position rotates the sacral
promontory and brings the aortic bifurcation close to the umbili-
cus, thus increasing chances of vascular injury (Pasic 1998). It also
states that intra-abdominal pressure should be used as a guide,
rather than the volume of infused carbon dioxide, to determine
when to site the primary trocar. Garry et al (Garry 1997) measured
the distance between the abdominal wall and underlying bowel
at different intra-abdominal pressures. They reported that at an
intra-abdominal pressure of 25 mm Hg the distance would be
10 cm. They also noted that even with difcult trocar insertion,
which could require a force of up to 4 to 5 kg, at an intra-abdom-
inal pressure of 25 mm Hg there would still be a safety distance of
5 cm between the abdominal wall and underlying structures. This
high intra-abdominal pressure should in theory minimise the risk
of visceral and vascular injury.
In 2007, a survey of gynaecologists with an interest in minimal
access surgery in the United Kingdom revealed a wide variation in
practice (Ahmad 2007). One-third of clinicians were unwilling to
change their practice unless supported by good quality evidence.
This systematic reviewaims to compare the different laparoscopic-
entry methods in terms of their inuence on intra-operative and
post-operative complications. This review will be updated every
two years, as per Cochrane Collaboration recommendations.
O B J E C T I V E S
To evaluate the benets and risks of different laparoscopic tech-
niques in gynaecological and non-gynaecological surgery.
M E T H O D S
Criteria for considering studies for this review
Types of studies
Randomised controlled trials (RCTs) were included when one la-
paroscopic port-entry technique was compared with another for
primary or secondary port entry.
Types of participants
Men, women and children undergoing diagnostic, operative or
mixed laparoscopy, performed either by gynaecologists or general
surgeons.
Types of interventions
The following laparoscopic-entry techniques were analysed.
1. Open-entry technique versus closed-entry technique:
1.1. open-entry technique versus direct-trocar entry;
1.2. open-entry technique versus Veress Needle entry technique.
2. Direct-trocar entry versus Veress Needle entry.
3. Direct-vision entry versus Veress Needle entry.
4. Direct-vision entry versus open-entry technique.
5. Disposable instruments versus reusable instruments.
6. Radially expanding (STEP) trocars versus standard trocars.
7. Trendelenburg position for entry versus supine position for
entry.
8. Volume of gas used as an indicator for entry versus intra-ab-
dominal pressure as an indicator for entry.
9. Comparisons of site of entry.
10. Comparisons of other laparoscopic-entry techniques for pri-
mary or secondary port insertion.
Types of outcome measures
Primary outcomes
Major complications
1. Mortality
2. Vascular injury (major vessels and abdominal wall vessels)
3. Visceral (bladder or bowel) injury
4. Gas embolism
5. Solid organ injury
6. Failed entry (unable to access the peritoneal cavity)
Secondary outcomes
Minor complications, such as extraperitoneal insufation and tro-
car site bleeding
Search methods for identication of studies
All published and unpublished RCTs studying laparoscopic en-
try techniques were sought. We used the following search strate-
gies, without language restriction and in consultation with the
Cochrane Menstrual Disorders and Subfertility Group (MDSG)
Trials Search Coordinator.
Electronic searches
We searched the following databases with no language restrictions.
1. The Cochrane Menstrual Disorders and Subfertility Groups
(MDSG) Specialised Register of controlled trials for any trials with
keywords in the title, abstract or keyword sections (Appendix 1).
2. Using Ovid software: MEDLINE (from 1966 to February
2011), EMBASE (from 1980 to February 2011), CENTRAL
(The Cochrane Library) (from 1980 to February 2011) and
PsycINFO (from1980 to February 2011) (Appendix 2; Appendix
3; Appendix 4; Appendix 5).
The MEDLINE search was combined with the Cochrane highly
sensitive search strategy for identifying randomised trials, which
appears in the searching chapter of the Cochrane Handbook for
Systematic Reviews of Interventions (Higgins 2011). The EMBASE
search was combined with trial lters developed by the Scottish In-
tercollegiate Guidelines Network (SIGN) (http://www.sign.ac.uk/
methodology/lters.html#random).
Other electronic sources of trials included:
Trial registers for ongoing and registered trials: Current
Controlled Trials (www.controlled-trials.com/);
ClinicalTrials.gov, a service of the US National Institutes of
Health (http://clinicaltrials.gov/ct2/home); and The World
Health Organization International Trials Registry Platform
search portal (www.who.int/trialsearch/Default.aspx).
Citation indexes (http://scientic.thomson.com/products/
sci/).
Conference abstracts in the ISI Web of Knowledge (http://
isiwebofknowledge.com/).
LILACS database, as a source of trials from the Portuguese
and Spanish speaking world (http://bases.bireme.br/cgibin/
wxislind.exe/iah/online/?IsisScript=iah/iah.xis&base=LILACS&
lang=i&form=F).
ClinicalStudyResults for clinical trial results of marketed
pharmaceuticals (www.clinicalstudyresults.org/).
PubMed (www.ncbi.nlm.nih.gov/pubmed/): the random
control lter for PubMed was taken from the searching chapter
of the Cochrane Handbook for Systematic.Reviews of Interventions.
For grey literature: OpenSIGLE database (http://
opensigle.inist.fr/); and Google.
Searching other resources
Grey literature was searched, and conference proceedings.The ref-
erence lists of articles retrieved by the search were handsearched
and any relevant journals and conference abstracts that are not
covered in the MDSG Specialised Register were handsearched in
liaison with the Trials Search Coordinator.
Data collection and analysis
Data collection and analysis was conducted in accordance with the
Cochrane Handbook for Systematic Reviews of Interventions (Higgins
2011).
Selection of studies
One review author scanned retrieved search results for relevant
titles and abstracts. Three review authors (GA, JD and HOF)
independently selected the trials to be included in accordance
with the above-mentioned criteria. Disagreements were resolved
by AW. Data were extracted and trials were analysed for the follow-
ing quality criteria, methodological details and descriptive data of
participants and outcomes. This information is presented in the
results section of the review and the table Characteristics of in-
cluded studies (Characteristics of included studies). Authors cor-
responded with study investigators to clarify study eligibility (for
example, with respect to participant eligibility criteria and alloca-
tion method).
Data extraction and management
Data were extracted from eligible studies independently by three
authors (GA, JD and HOF). All discrepancies were resolved by
AW. Additional information on trial methodology and trial data
were sought from the authors of trials that appeared to meet the
eligibility criteria but had aspects of methodology that were un-
clear, or data that were in a form unsuitable for meta-analysis.
Assessment of risk of bias in included studies
Each included trial was assessed for the following criteria using the
Cochrane risk of bias assessment tool: sequence generation, allo-
cation concealment, blinding of participants, providers and out-
come assessors; completeness of outcome data; selective outcome
reporting; and other potential sources of bias (Higgins 2011). The
conclusions were presented in the Risk of bias table and were
incorporated into the interpretation of review ndings by means
of sensitivity analyses. Three review authors (GA, JD and HOF)
independently performed all assessments of the quality of trials.
All discrepancies were resolved by AW.
In viewof the difculty in detecting and correcting for publication
bias and other reporting biases, the authors aimed to minimise the
potential impact by ensuring a comprehensive search for eligible
studies and by being alert for duplication of data. If there were 10
or more studies in an analysis, a funnel plot was used to explore
the possibility of small study effects (a tendency for estimates of
the intervention effect to be more benecial in smaller studies).
Care was taken to search for within study reporting bias, such as
trials failing to report obvious outcomes (for example, failed entry,
major complications), or reporting them in insufcient detail to
allow inclusion.
Measures of treatment effect
The numbers of events in the control and intervention groups
of each study were used to calculate odds ratios (Peto OR) with
95% condence intervals (CI). Statistical analysis was performed
in accordance with the guidelines for statistical analysis in Section
8 of the Cochrane Handbook (Higgins 2011).
Unit of analysis issues
The primary analysis was per participant randomised.
Dealing with missing data
The data were analysed on an intention-to-treat (ITT) basis as
far as possible and attempts were made to obtain missing data
from the original investigators. Complications were assumed not
to have occurred in participants with unreported outcome. For all
outcomes, only the available data were analysed.
Assessment of heterogeneity
The authors considered whether the clinical and methodologi-
cal characteristics of the included studies were sufciently simi-
lar for meta-analysis to provide a meaningful summary. Statisti-
cal heterogeneity was assessed by the measure of the I
2
statistic.
An I
2
value greater than 50% indicates substantial heterogeneity
(Higgins 2011) and where present was addressed through sensi-
tivity or subgroup analysis, or both.
Assessment of reporting biases
In viewof the difculty in detecting and correcting for publication
bias and other reporting biases, the authors aimed to minimise
their potential impact by ensuring a comprehensive search for
eligible studies and by being alert for duplication of data. If there
were 10 or more studies in an analysis, a funnel plot was planned
to explore the possibility of small study effects (a tendency for
estimates of the intervention effect to be more benecial in smaller
studies).
Data synthesis
Data from primary studies were combined using a xed-effect
model with RevMan software.
An increase in the odds of a particular outcome was displayed
graphically in the meta-analyses to the right of the centre-line and
a decrease in the odds of an outcome to the left of the centre-line.
Subgroup analysis and investigation of heterogeneity
Heterogeneity was explored by performing subgroup analysis for
the following interventions:
1. Open-entry technique versus closed-entry technique.
a. Open-entry technique versus Veress Needle entry technique.
b. Open-entry technique versus direct-trocar entry.
Where only single RCTs were identied for an intervention, re-
sults were interpreted with caution and did not form part of the
conclusion. During data extraction, population groups excluded
from studies were identied for individual interventions and the
effect upon the applicability of results to the general population
was considered in the conclusions drawn from the results.
Sensitivity analysis
Sensitivity analyses were conducted for the primary outcomes to
determine whether the conclusions were robust to arbitrary de-
cisions made regarding the eligibility of studies and analysis. We
aimed to perform a sensitivity analysis where eligibility was re-
stricted to studies without high risk of bias.
R E S U L T S
Description of studies
See: Characteristics of includedstudies; Characteristics of excluded
studies.
Description of studies
Twenty-eight randomised controlled studies (RCTs) were identi-
ed, covering 13 different laparoscopic-entry techniques. Further
descriptive details about the included studies are provided in the
table Characteristics of included studies. Eleven new studies were
included, with 1867 participants, in the updated review (Akbar
2008; Bisgaard 2007; Lam 2000; Ghezzi 2005; Hamade 2007;
Minervini 2008; Tinelli 2010; Tsimoyiannis 2009; Venkatesh
2007; Yim 2001; Zakerah 2010). All included trials were pub-
lished reports (full papers or abstracts). Bemelman 1 2000 under-
took a multi-arm trial comparing the Hasson trocar with a direct-
entry trocar and the Veress Needle. For that reason, the study was
given three identities (IDs) so that the data could be used in meta-
analyses, as Bemelman 1 2000 (open entry versus direct-trocar en-
try), Bemelman 2 2000 (open entry versus Veress Needle entry),
and Bemelmen 3 2000 (direct-trocar entry versus Veress Needle
entry). Tansatit 1 2006 undertook a multi-arm trial comparing
the direct trocar with the Veress Needle and the reusable pyrami-
dal trocar. For that reason, the study was given three IDs so that
the data could be used in meta-analysis, as Tansatit 1 2006 (direct
trocar versus Veress Needle), Tansatit 2 2006 (direct trocar versus
Veress Needle), and Tansatit 3 2006 (direct trocar versus reusable
pyramidal trocar). Yim2001 compared a radially expanding access
device with a cutting-tip trocar. Both trocars were inserted at a
secondary port site (right or left side) allocated through computer-
generated randomisation.
Participants
Twenty-eight RCTs with a total of 4860 individuals undergo-
ing laparoscopy were included in the systematic review (Agresta
2004; Akbar 2008; Bemelman 1 2000; Bhoyrul 2000; Bisgaard
2007; Borgatta 1990; Briel 2000; Byron 1993; Cogliandolo 1998;
Cravello 1999; Lam 2000; Feste 2000; Ghezzi 2005; Gunec
2005; Hamade 2007; Johnson 1997; Kitano 1993; Mettle 2000;
Minervini 2008; Ostrzenski 1999; Santala 1999; Schulze 1999;
Tansatit 1 2006; Tinelli 2010; Tsimoyiannis 2009; Venkatesh
2007; Yim 2001; Zakerah 2010).
The number of participants included in each trial ranged from 17
(Schulze 1999) to 1000 (Zakerah 2010).
Exclusion criteria were not stated in Borgatta 1990, Byron 1993,
Cogliandolo 1998, Feste 2000, Gunec 2005, Minervini 2008,
Yim 2001 and Zakerah 2010. The other trials stated that ex-
clusion would be based on participant characteristics, including
age (Bemelman 1 2000; Bisgaard 2007; Hamade 2007; Johnson
1997; Lam 2000; Venkatesh 2007) and obesity (Agresta 2004;
Bemelman 1 2000; Briel 2000; Tinelli 2010; Tsimoyiannis 2009).
The trials also based their exclusion criteria on the presence of
acute inammatory conditions (Bhoyrul 2000; Lam2000; Mettle
2000; Ostrzenski 1999; Santala 1999; Tansatit 1 2006), adhesive
disease (Byron 1993; Ostrzenski 1999; Santala 1999; Tansatit 1
2006), endometriosis (Ghezzi 2005; Ostrzenski 1999), and in-
tra-abdominal malignancy (Byron 1993; Cravello 1999; Ghezzi
2005; Lam 2000; Schulze 1999; Tinelli 2010). Exclusion was
also based on the presence of bowel distension (Agresta 2004;
Ostrzenski 1999; Tansatit 1 2006), cardio-pulmonary disease
(Ostrzenski 1999), paraumbilical hernia (Akbar 2008), diaphrag-
matic hernia (Ostrzenski 1999), stula formation (Ostrzenski
1999), irritable bowel disease (Ostrzenski 1999), intestinal ob-
struction (Byron 1993), pregnancy (Byron 1993), uterine broids
(Santala 1999), uterine length of over 10 cm (Santala 1999), rec-
tal surgery (Schulze 1999), concomitant incidence for hysterec-
tomy or myomectomy (Ghezzi 2005), chronic pain disease and
previous analgesics (Bisgaard 2007), uncontrolled systemic ill-
ness (Akbar 2008), large ovarian cysts (Tinelli 2010), gall bladder
pathology (Kitano 1993), signs of acute cholecystitis or choledo-
cholithiasis or attacks of acute pancreatitis(Tsimoyiannis 2009),
ASA grade more than II (Tsimoyiannis 2009), and lack of written
informed consent (Tsimoyiannis 2009). Laparoscopic entry was
required for gynaecological abdominal surgery, except for Agresta
2004, Akbar 2008, Bemelman 1 2000, Bhoyrul 2000, Bisgaard
2007, Briel 2000, Cogliandolo 1998, Kitano 1993, Kitano 1993,
Tsimoyiannis 2009, and Venkatesh 2007 where laparoscopic entry
was required for non-gynaecological abdominal surgery.
Previous abdominal surgery
Several trials based their exclusion criteria on a history of abdom-
inal operations (Agresta 2004; Akbar 2008; Bemelman 1 2000;
Briel 2000; Byron 1993; Cravello 1999; Kitano 1993; Ostrzenski
1999; Tansatit 1 2006; Tinelli 2010). The remaining studies in-
cluded participants with a history of abdominal operations. There
was no statistical signicance between study groups in these RCTs
(Bhoyrul 2000; Borgatta 1990; Cogliandolo 1998; Feste 2000;
Gunec 2005; Johnson 1997; Mettle 2000; Santala 1999; Zakerah
2010).
Interventions
The interventions studied are listed below, together with the iden-
tied studies.
1. Open-entry technique versus closed-entry (Veress Needle or
direct-trocar) technique. Three RCTs investigated an open-entry
technique with a closed-entry technique (direct trocar or Veress
Needle) (Akbar 2008; Bemelman 1 2000; Bemelman 2 2000;
Cogliandolo 1998).
1.1. Open-entry technique versus direct-trocar entry. One
RCT investigated an open technique with direct-trocar entry
(Bemelman 1 2000).
1.2. Open-entry technique versus Veress Needle entry. Three RCTs
investigated an open technique with Veress Needle entry (Akbar
2008; Bemelman 2 2000; Cogliandolo 1998).
2. Direct-trocar entry versus Veress Needle entry. Six RCTs inves-
tigated direct-trocar entry with Veress Needle entry (Agresta 2004;
Bemelmen 3 2000; Borgatta 1990; Byron 1993; Gunec 2005;
Tansatit 1 2006; Tansatit 2 2006; Zakerah 2010).
3. Direct-vision entry versus Veress Needle entry. One RCTinves-
tigated direct-vision entry with Veress Needle entry (Tinelli 2010).
4. Direct-vision entry versus open-entry technique. One RCT in-
vestigated direct-vision entry versus an open technique (Minervini
2008).
5. Disposable instruments versus reusable instruments. No RCTs
were identied.
6. Radially expanding (STEP) trocars versus standard trocars. Four
RCTs compared radially expanding (STEP) trocars with standard
trocars (Bhoyrul 2000; Bisgaard 2007; Feste 2000; Mettle 2000).
7. Trendelenburg position for entry versus supine position for
entry. No RCTs were identied.
8. Volume of gas used as an indicator for entry versus intra-abdom-
inal pressure as an indicator for entry. No RCTs were identied.
9. Comparisons of site of entry. Trans-fundal versus infra-umbilical
insertion of the Veress Needle.
A single RCT compared the trans-fundal with the infra-umbilical
position for Veress Needle insertion (Santala 1999).
10. Any other laparoscopic-entry technique compared with any
other laparoscopic-entry technique for primary port andsecondary
port insertion:
10.1. lifting and not lifting the abdominal wall before Veress Nee-
dle insertion, a single RCT compared lifting and not lifting the
abdominal wall before Veress Needle insertion (Briel 2000);
10.2. carbon dioxide gas insufation versus the use of a gasless
abdominal-wall retractor, four RCTs compared carbon dioxide
gas insufation with the use of a gasless abdominal-wall retractor
(Cravello 1999; Johnson 1997; Kitano 1993; Schulze 1999);
10.3. a closed technique versus a parallel technique of Veress Nee-
dle insertion, a single RCT compared a closed technique with a
parallel technique of Veress Needle insertion (Ostrzenski 1999);
10.4. direct-entry trocar versus reusable pyramidal trocar, a single
RCT compared the use of a direct-entry (missile) trocar with a
reusable pyramidal trocar (Tansatit 3 2006);
10.5. cutting trocar versus blunt trocar, two RCTs compared cut-
ting trocars with blunt trocars (Hamade 2007; Venkatesh 2007);
10.6. SILS cholecystectomy versus classic laparoscopic cholecys-
tectomy, a single RCT compared SILS cholecystectomy versus
classic laparoscopic cholecystectomy (Tsimoyiannis 2009);
10.7. 5 mm versus 3 mm secondary port entry, a single RCT
compared 5 mm secondary port entry with 3 mm secondary port
entry (Ghezzi 2005);
10.8. radially expanding access device (STEP) and conventional
cutting tip trocar for secondary port entry, two RCTs compared
the STEP with a conventional cutting tip trocar (Lam 2000; Yim
2001).
Intervention standardisation
Several RCTs stated clearly that all operators had received stan-
dardised operative training in both interventions especially for
the study (Agresta 2004; Bemelman 1 2000; Cogliandolo 1998;
Kitano 1993; Mettle 2000; Ostrzenski 1999; Santala 1999;
Tansatit 1 2006). Several RCTs also stated clearly that a standard-
ised operative technique was deployed by all operators (Agresta
2004; Akbar 2008; Bhoyrul 2000; Bisgaard 2007; Bemelman 1
2000; Cogliandolo 1998; Cravello 1999; Ghezzi 2005; Gunec
2005; Hamade 2007; Johnson 1997; Kitano 1993; Mettle 2000;
Ostrzenski 1999; Santala 1999; Schulze 1999; Tansatit 1 2006;
Tinelli 2010; Tsimoyiannis 2009; Yim 2001; Zakerah 2010).
Outcomes
Studies reported the following primary outcome measures.
1. Mortality (Agresta 2004; Bemelman 1 2000; Bemelman 2
2000).
2. Vascular injury (Agresta 2004; Bhoyrul 2000; Cogliandolo
1998; Cravello 1999; Feste 2000; Kitano 1993; Mettle 2000;
Ostrzenski 1999; Venkatesh 2007). Only two studies stated a clear
denition for vascular injury (Mettle 2000: major vascular injury
and abdominal wall vascular injury; and Ostrzenski 1999: lacera-
tion of large blood vessels).
3. Visceral (bladder or bowel) injury (Agresta 2004; Bhoyrul
2000; Briel 2000; Cogliandolo 1998; Feste 2000; Mettle 2000;
Ostrzenski 1999; Tinelli 2010; Venkatesh 2007).
4. Gas embolism (Agresta 2004; Borgatta 1990).
5. Solid organ injury (Agresta 2004; Bhoyrul 2000; Kitano 1993;
Minervini 2008).
6. Failed entry (unable to access the peritoneal cavity) (Agresta
2004; Akbar 2008; Borgatta 1990; Briel 2000; Byron1993; Gunec
2005; Mettle 2000; Minervini 2008; Santala 1999; Zakerah
2010).
Studies reported the following secondary outcome measures.
7. Extraperitoneal insufation (Agresta 2004; Akbar 2008;
Borgatta 1990; Briel 2000; Byron1993; Cogliandolo 1998; Gunec
2005; Kitano 1993; Ostrzenski 1999; Zakerah 2010).
8. Trocar site bleeding (Bhoyrul 2000; Bisgaard 2007; Cogliandolo
1998; Cravello 1999; Ghezzi 2005; Hamade 2007; Lam 2000;
Mettle 2000; Minervini 2008; Tinelli 2010; Venkatesh 2007; Yim
2001).
9. Infection (Akbar 2008; Borgatta 1990; Cogliandolo 1998;
Cravello 1999; Kitano 1993, Lam 2000; Venkatesh 2007; Yim
2001).
10. Incisional hernia (Bhoyrul 2000; Yim 2001).
11. Omentum injury (Akbar 2008; Borgatta 1990; Zakerah
2010).
12. Uterine bleeding (Santala 1999).
Results of the search
Thirty-one trials were identiedas potentially eligible for inclusion
within the review. Three trials were excluded, as detailed below.
Included studies
Twenty-eight randomised controlled trials were identied, cover-
ing 13 different laparoscopic-entry techniques and including 4860
participants.
Excluded studies
Three trials were excluded from the review. Joshipura 2009 and
Sandhu 2009 compared different interventions to maintain the
pneumoperitoneum, whilst Kim 2009 investigated the different
surgical approaches which could be deployed to perform laparo-
scopic cholecystectomy.
Risk of bias in included studies
Further quality details about the included studies are provided in
the table Characteristics of included studies; Figure 1 and Figure
2.
Figure 1. Risk of bias graph: review authors judgements about each risk of bias item presented as
percentages across all included studies.
Figure 2. Risk of bias summary: review authors judgements about each risk of bias item for each included
study.
Trial design
All included trials stated that they were randomised controlled
trials (RCTs).
Allocation
Allocation concealment was unclear in all the studies except Akbar
2008, Agresta 2004; Bisgaard 2007, Tsimoyiannis 2009 and Yim
2001 (sealed envelopes).
Blinding
Four RCTs were single-blinded: Ghezzi 2005, Lam 2000,
Johnson 1997 (patient); Tsimoyiannis 2009 (observer). Five
RCTs (Bisgaard 2007; Bhoyrul 2000; Feste 2000; Mettle 2000;
Ostrzenski 1999) (patient and observer) were double-blinded
RCTs.
Incomplete outcome data
Several RCTs did not report any of our outcome measures. In
Johnson 1997 outcome measures included operative technique
andpatient pain. Tansatit 1 2006 reportedoperative technique and
patient pain. Tsimoyiannis 2009 reported the ease of the operative
technique. Further information was requested fromthese authors.
Three RCTs reported exclusion of participants with the reasons
for doing so (Bhoyrul 2000; Cravello 1999; Tsimoyiannis 2009).
Two RCTs reported participants as lost to follow up because of
intra-operative complications (Feste 2000; Schulze 1999).
Bisgaard 2007 reported one participant as lost to follow up due to
loss of a study diary.
Exclusions were stated but reasons not given in Akbar 2008.
All other studies either stated no exclusions, loss to follow up, or
drop-outs; or exclusions were not mentioned within the study.
Selective reporting
The level of selective reporting was low for the studies. Data were
presented as number of cases and percentages with no conversion
of data. P values were stated for each outcome with no omission
of outcomes and no subsets of data.
Within 10 studies, P values were not stated for every outcome
(Agresta 2004; Bisgaard 2007; Cravello1999; Feste 2000; Johnson
1997; Kitano 1993; Minervini 2008; Ostrzenski 1999; Santala
1999; Venkatesh 2007).
Bisgaard 2007 presented subgroups of data in relation to the level
of suggillations and nausea and vomiting.
Zakerah 2010 used differing statistical analysis between outcomes.
Other potential sources of bias
Generation of random sequence
Randomisation by random number tables was clearly stated in
Bhoyrul 2000; Byron 1993; Cravello 1999; Johnson 1997; Kitano
1993; Mettle 2000; or by computerised random number selection
(Bisgaard 2007; Cogliandolo 1998, Ghezzi 2005; Hamade 2007;
Yim 2001; Zakerah 2010). In the remaining studies the method
of randomisation was unclear (Agresta 2004; Bemelman 1 2000;
Borgatta 1990; Briel 2000; Feste 2000; Gunec 2005; Ostrzenski
1999; Santala 1999; Schulze 1999; Tansatit 1 2006; Tinelli 2010;
Venkatesh 2007).
Power calculation
Four RCTs undertook a power calculation (Agresta 2004; Bisgaard
2007; Tsimoyiannis 2009; Venkatesh 2007).
Intention to treat and losses to follow up
Intention to treat was referred to and used in three trials (Agresta
2004; Bhoyrul 2000; Feste 2000). The other trials made no refer-
ence to an intention-to-treat analysis and there was no indication
that it had been used.
Source of funding
The source of funding was unclear in all trials except for Tansatit
1 2006 and Schulze 1999. Tansatit 1 2006 was supported by
the Ratchadapiseksompotch Fund, Chulalongkorn University;
Schulze 1999 was supported by a grant fromAGAAB Medicinska
Forskningsford, Sweden. The STEP trocars were supplied free of
charge by Kojima Healthcare Asia Ltd for Lam 2000.
Exclusion of participants
The strict inclusion criteria of the trials requires the results to
be interpreted with caution in terms of relevance to the general
population.
Effects of interventions
See: Summary of ndings for the main comparison Open
entry technique versus closed entry technique for women
undergoing laparoscopy; Summary of ndings 2 Direct trocar
entry compared to Veress Needle entry for women undergoing
laparoscopy; Summary of ndings 3 Direct vision entry
compared to Veress Needle entry for women undergoing
laparoscopy; Summary of ndings 4 Direct vision entry
compared to Open entry technique for women undergoing
laparoscopy; Summary of ndings 5 Radially expanding (STEP)
trocars for primary port entry compared to Standard trocars
for women undergoing laparoscopy; Summary of ndings 6
Cutting trocar compared to Blunt trocars for women undergoing
laparoscopy; Summary of ndings 7 Transfundal insertion of
the Veress Needle compared to Infra-umbilical insertion of the
Veress Needle for women undergoing laparoscopy; Summary
of ndings 8 Lifting the abdominal wall before Veress Needle
insertion compared to Not lifting the abdominal wall before Veress
Needle insertion for women undergoing laparoscopy; Summary
of ndings 9 Carbon dioxide gas insufation compared to The
use of a gasless abdominal wall retractor for women undergoing
laparoscopy; Summary of ndings 10 A closed technique
compared to A parallel technique of Veress Needle insertion for
women undergoing laparoscopy; Summary of ndings 11 5
mm secondary port trocars compared to 3 mm secondary port
trocars for women undergoing laparoscopy; Summary of ndings
12 Radially expanding (STEP) secondary trocars compared to
Standard secondary trocars for women undergoing laparoscopy
1. Open-entry technique versus closed-entry
technique (primary port entry)
Three RCTs (Akbar 2008; Bemelman 1 2000; Bemelman 2 2000;
Cogliandolo 1998) with a total of 260 participants compared
an open-entry technique versus a closed-entry technique (direct
trocar or Veress Needle) (Summary of ndings for the main
comparison).
Primary outcomes
1.1 Mortality
One RCT (Bemelman 1 2000; Bemelman 2 2000) compared an
open-entry technique versus direct-trocar or Veress Needle entry.
There were no events in any group (Analysis 1.1).
1.2 Vascular injury
One RCT(Cogliandolo 1998) compared anopen-entry technique
versus Veress Needle entry. There was no signicant difference
between the groups in vascular injury rates: OR 0.14 (95% CI
0.00 to 6.82; Analysis 1.2).
1.3 Visceral injury
One RCT(Cogliandolo 1998) compared anopen-entry technique
versus Veress Needle entry. There was no signicant difference
between the groups in visceral injury rates: OR1.00 (95%CI 0.06
to 16.14; Analysis 1.3).
1.4 Gas embolism
This outcome was not reported.
1.5 Solid organ injury
1.6 Failed entry
One RCT(Akbar 2008) compared anopen-entry technique versus
Veress Needle entry. The open-entry technique was associatedwith
a signicant reduction in incidence of failed entry: OR 0.12 (95%
CI 0.02 to 0.92; Analysis 1.6).
Secondary outcomes
There was no evidence of a signicant difference between closed-
entry or open-entry techniques in rates of extraperitoneal insuf-
ation (OR 0.36, 95% CI 0.05 to 2.61, two RCTs; Analysis 1.7),
trocar site bleeding (OR 0.14, 95% CI 0.00 to 6.82, one RCT;
Analysis 1.8), trocar site infection (OR1.21, 95%CI 0.36 to 4.04,
two RCTs; Analysis 1.9), or injury to the mesentery (OR 0.14,
95% CI 0.00 to 6.82; Analysis 1.10).
Bemelman 1 2000 and Bemelman 2 2000 reported no complica-
tions in either group for any outcome measure.
2. Direct-trocar entry versus Veress Needle entry
(primary port entry)
Seven RCTs investigated direct-trocar entry with Veress Needle
entry (Agresta 2004; Bemelmen 3 2000; Borgatta 1990; Byron
1993; Gunec 2005; Tansatit 1 2006; Tansatit 2 2006; Zakerah
2010), with a total of 2909 participants. Bemelmen 3 2000;
Tansatit 1 2006 and Tansatit 2 2006 reported no complications
in either group (Summary of ndings 2).
Primary outcomes
2.1 Mortality
Two RCTs (Agresta 2004; Bemelmen 3 2000) reported this out-
come. There were no events in either arm (Analysis 2.1).
2.2 Vascular injury
One RCT reported this outcome (Agresta 2004). There were no
events in either arm (Analysis 2.2).
2.3 Visceral injury
One RCT reported this outcome (Agresta 2004). There were no
events in either arm (Analysis 2.3).
2.4 Gas embolism
Two RCTs (Agresta 2004; Borgatta 1990) reported this outcome.
There were no events in either arm (Analysis 2.4).
One RCT reported this outcome (Agresta 2004). There was no
statistically signicant difference between the groups (OR 0.16,
95% Cl 0.01 to 2.53; Analysis 2.5).
2.6 Failed entry
Five RCTs reported this outcome (Agresta 2004; Borgatta 1990;
Byron 1993; Gunec 2005; Zakerah 2010). Meta-analysis demon-
strated a reduction in failed entry into the abdomen with the use
of direct-trocar entry in comparison to the Veress Needle entry
technique (OR 0.21, 95% Cl 0.14 to 0.31; Analysis 2.6). Sensi-
tivity analysis by excluding all studies with unclear randomisation
found that the reduction in failed entry was still signicant: OR
0.21 (95% CI 0.14 to 0.33).
Secondary outcomes
Meta-analysis demonstrated a signicant reduction in rates of ex-
traperitoneal insufation and omentum injury associated with the
use of direct-trocar entry when compared to Veress Needle entry:
OR 0.18 (95% Cl 0.13 to 0.26, ve RCTs; Analysis 2.7) and OR
0.28 (95% CI 0.14 to 0.55, two RCTs; Analysis 2.10), respec-
tively.
There was no signicant difference between the groups in wound
infection rates: OR 0.15 (95% CI 0.00 to 7.36; Analysis 2.9).
Sensitivity analysis by excluding all studies with unclear randomi-
sation demonstrated that the reduction in complication rate with
the use of direct trocar in comparison to the Veress Needle was still
signicant for the outcomes of extraperitoneal insufation (OR
0.20, 95% CI 0.13, 0.31) and omental injury (OR 0.19, 95% CI
0.08, 0.44).
3. Direct-vision entry versus Veress Needle entry
A single RCT (Tinelli 2010) with a total of 194 participants in-
vestigated direct-vision entry with Veress Needle entry (Summary
of ndings 3).
Primary outcomes
3.1 Mortality
3.2 Vascular injury
3.3 Visceral injury
There was no signicant difference between the groups for this
outcome: OR 0.15 (95% CI 0.01 to 2.34; Analysis 3.3).
3.4 Gas embolism
3.6 Failed entry
Secondary outcomes
There was no signicant difference between the groups in rates
of trocar site bleeding: OR 0.55 (95% CI 0.11 to 2.78; Analysis
3.8).
4. Direct-vision entry versus open technique (primary
port entry)
A single RCT (Minervini 2008) with a total of 60 participants in-
vestigated direct-vision entry versus an open technique (Summary
of ndings 4).
Primary outcomes
4.1 Mortality
4.2 Vascular injury
4.3 Visceral injury
4.4 Gas embolism
outcome: OR 6.16 (95% CI 0.12 to 316.67, one RCT; Analysis
4.5).
4.6 Failed entry
outcome: OR0.40 (95%CI 0.04 to 4.09, one RCT; Analysis 4.6).
Secondary outcomes
There was no signicant difference between the groups in rates of
trocar site bleeding: OR 6.16 (95% CI 0.12 to 316.67; Analysis
4.8).
5. Disposable instruments versus reusable
instruments (primary port entry)
No RCTs were identied for this comparison.
6. Radially expanding (STEP) trocars versus standard
trocars (primary port entry)
See: Summary of results table 5.
Four RCTs with a total of 514 participants investigated the use
of radially expanding (STEP) trocars with standard trocars for
laparoscopic entry (Bhoyrul 2000; Bisgaard 2007; Feste 2000;
Mettle 2000).
Primary outcomes
6.1 Mortality
No RCTs reported this outcome.
6.2 Vascular injury
outcome: OR 0.24 (95% Cl 0.05 to 1.21, two RCTs; Analysis
6.2).
6.3 Visceral injury
outcome: OR 0.13 (95% CI 0.00 to 6.37, two RCTs; Analysis
6.3).
6.4 Gas embolism
outcome: OR 1.05 (95% CI 0.07 to 16.91, one RCT; Analysis
6.5).
6.6 Failed entry
Secondary outcomes
Meta-analysis demonstrated that radially expanding (STEP) tro-
cars were associatedwitha signicant reductionintrocar site bleed-
ing when compared to standard trocar entry: OR 0.31 (95% Cl
0.15 to 0.62, three RCTs; Analysis 6.8). However, this analysis
demonstrated heterogeneity with an I
2
of 60%.
7 Trendelenburg position for entry versus supine
position for entry (primary port entry)
No RCTs were found for this comparison.
8 Volume of gas used as an indicator for entry versus
intra-abdominal pressure as an indicator for entry
No RCTs were found for this comparison.
9. Comparisons of sites of entry
9.1 Transfundal versus infra-umbilical insertion of the Veress
Needle (primary port entry)
One RCT (Santala 1999) investigated transfundal versus infra-
umbilical insertion of the Veress Needle (Analysis 9.1; Summary
of ndings 7).
Primary outcomes
9.1.1 Mortality
9.1.2 Vascular injury
9.1.3 Visceral injury
9.1.4 Gas embolism
9.1.5 Solid organ injury
9.1.6 Failed entry
There was no signicant difference between the groups in failed
entry rates: OR 0.14 (95% CI 0.00 to 6.82).
Secondary outcomes
There was no signicant difference between the groups in uterine
bleeding rates: OR 7.70 (95% CI 0.78 to 75.76).
10. Comparisons of other laparoscopic-entry
techniques for primary or secondary port insertion
Eight RCTs compared other laparoscopic-entry techniques.
10.1 Lifting versus not lifting the abdominal wall before
Veress Needle insertion (primary port entry)
One RCT (Briel 2000) with 150 participants reported this com-
parison (Analysis 10.1; Summary of ndings 8).
Primary outcomes
10.1.1 Mortality
Briel 2000 reported this outcome. There were no cases of visceral
injury in either study arm.
10.1.4 Gas embolism
10.1.6 Failed entry
Not lifting the abdominal wall before Veress Needle insertion was
associated with a signicantly lower rate of failed entry than with
lifting: OR 4.44 (95% CI 2.16 to 9.13).
Secondary outcomes
extraperitoneal insufation: OR4.43 (95% CI 0.98 to 20.10, one
RCT).
10.2 Carbon dioxide gas insufation versus the use of a
gasless abdominal wall retractor (primary port entry)
Four RCTs with a total of 212 participants investigated the use of
carbon dioxide gas insufation versus the use of a gasless abdom-
inal wall retractor (Cravello 1999; Johnson 1997; Kitano 1993;
Schulze 1999) (Analysis 10.2; Summary of ndings 9).
Primary outcomes
10.2.1 Mortality
outcome: OR 7.23 (95% CI 0.45 to 115.64, two RCTs).
10.2.4 Gas embolism
10.2.6 Failed entry
Secondary outcomes
Meta-analysis demonstrated no signicant difference between the
use of carbon dioxide gas insufation and a gasless abdominal wall
retractor in rates of extraperitoneal insufation (OR 7.58, 95%
CI 0.77 to 74.97, one RCT), trocar site bleeding (OR 0.13, 95%
CI 0.00 to 6.69), or wound infection (OR 0.98, 95% CI 0.06 to
15.87).
10.3 A closed technique versus a parallel technique of Veress
Needle insertion (primary port entry)
A single RCT with 200 participants compared a closed technique
with a parallel technique of Veress Needle insertion (Ostrzenski
1999) (Summary of ndings 10).
10.3.1 Mortality
This outcome was measured but there were no events in either
group.
This outcome was measured but there were no events in either
group.
10.3.4 Gas embolism
10.3.6 Failed entry
Secondary outcomes
Extraperitoneal insufation was measured, but there were no
events in either group.
10.4. Direct-entry trocar versus reusable pyramidal trocar
A single study (Tansatit 1 2006) undertook a multi-armtrial. This
was a single-blindedRCTwith100participants. Nocomplications
were reported in either group.
10.5 Cutting trocars versus blunt trocars (primary port
entry)
Two RCTs including 195 participants investigated the use of a
cutting trocar with blunt trocars (Hamade 2007; Venkatesh 2007)
(Analysis 10.5; Summary of ndings 6).
Primary outcomes
10.5.1 Mortality
One RCT (Venkatesh 2007) reported this outcome. There was no
signicant difference between the groups: OR 7.67 (95% CI 0.15
to 386.69).
10.5.4 Gas embolism
10.5.6 Failed entry
Secondary outcomes
There was no signicant difference between the two groups in
rates of trocar site bleeding (OR 0.33, 95% CI 0.09 to 1.23, two
RCTs) or wound infection (OR 7.67, 95% CI 0.15 to 386.69,
one RCT).
10.6 SILS versus classic laparoscopic cholecystectomy
A single RCT was identied, including 40 participants, which in-
vestigated the use of SILS entry to classic laparoscopic cholecys-
tectomy. No complications were reported (Tsimoyiannis 2009).
10.7 A 5 mm versus 3 mm secondary port entry
A single RCT (Ghezzi 2005) with a total of 102 participants com-
pared a 5 mm secondary port entry with a 3 mm secondary port
entry (Summary of ndings 11).
Primary outcomes
None of the reviews primary outcomes were reported.
Secondary outcomes
trocar site bleeding (OR 0.14, 95% CI 0.01 to 2.24).
10.8 Radially expanding access device and conventional
cutting tip trocar
Two RCTs (Lam 2000; Yim2001) with a total of 129 participants
compared a radially expanding access device with a conventional
cutting tip trocar (Summary of ndings 5).
Primary outcomes
None of the reviews primary outcomes were reported.
Secondary outcomes
Radially expanding (STEP) secondary port trocars were associated
with lower rates of trocar site bleeding compared to standard sec-
ondary port trocars (OR 0.12, 95% CI 0.02 to 0.92). There was
no signicant difference between the groups in rates of trocar site
infection with either technique (OR 0.14, 95% CI 0.01 to 2.21).
A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]
Direct trocar entry compared to Veress Needle entry for women undergoing laparoscopy
Patient or population: patients with women undergoing laparoscopy
Settings: Surgical
Intervention: Direct trocar entry
Comparison: Veress Needle entry
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Veress Needle entry Direct trocar entry
Solid organ injury
6 per 1000 1 per 1000
(0 to 16)
OR 0.16
(0.01 to 2.53)
598
(1 study)
very low
1,2,3
tion
81 per 1000 16 per 1000
(11 to 23)
OR 0.18
(0.13 to 0.26)
2640
(5 studies)
moderate
1
Omentum injury
44 per 1000 13 per 1000
(6 to 25)
OR 0.28
(0.14 to 0.55)
1212
(2 studies)
low
1,4
9 per 1000 1 per 1000
(0 to 63)
OR 0.15
(0 to 7.36)
212
(1 study)
very low
1,3,5
Failed entry
69 per 1000 15 per 1000
(10 to 22)
OR 0.21
(0.14 to 0.31)
2640
(5 studies)
moderate
1
1
9
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Summary effect cross the line of no effect and appreciable harm and benefit
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx
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Direct vision entry compared to Veress Needle entry for women undergoing laparoscopy
Settings: Surgical
Intervention: Direct vision entry
Comparison: Veress Needle entry
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Veress Needle entry Direct vision entry
Major outcome - Vis-
ceral injury (bowel)
20 per 1000 4 per 1000
(0 to 83)
OR 0.21
(0.01 to 4.49)
194
(1 study)
very low
1,2,3
40 per 1000 21 per 1000
(4 to 109)
OR 0.53
(0.1 to 2.98)
194
(1 study)
very low
1,2,3
1
There were inadequate details for randomisation, allocation concealment and blinding
2
Summary effect crossed the line of no effect and appreciable harm or benefit
3
Evidence based on a single trial
2
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Direct vision entry compared to Open entry technique for women undergoing laparoscopy
Settings: Surgical
Intervention: Direct vision entry
Comparison: Open entry technique
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Open entry technique Direct vision entry
Major complications -
Solid organ injury
0 per 1000 0 per 1000
(0 to 0)
OR 2.54
(0.1 to 64.86)
60
(1 study)
very low
1,2,3
Minor complications -
0 per 1000 0 per 1000
(0 to 0)
OR 2.54
(0.1 to 64.86)
60
(1 study)
very low
1,2,3
Major complications -
Failed entry
74 per 1000 30 per 1000
(2 to 267)
OR 0.39
(0.03 to 4.56)
60
(1 study)
very low
1,3,4
1
There were inadequate details for randomisation, allocation concealment and blinding
2
Summary effect crossed the line of no effect and appreciable harm and benefit
3
4
Summary effect crossed the line of no effect and appreciable benefit or harm 2
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Radially expanding (STEP) trocars compared to Standard trocars for women undergoing laparoscopy
Settings: Surgical
Intervention: Radially expanding (STEP) trocars
Comparison: Standard trocars
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Standard trocars Radially expanding
(STEP) trocars
Solid organ injury
8 per 1000 8 per 1000
(1 to 120)
OR 1.05
(0.07 to 16.91)
244
(1 study)
very low
1,2,3
Vascular injury
30 per 1000 7 per 1000
(2 to 36)
OR 0.24
(0.05 to 1.21)
331
(2 studies)
moderate
1
Visceral injury
6 per 1000 1 per 1000
(0 to 37)
OR 0.13
(0 to 6.37)
331
(2 studies)
low
1,4
135 per 1000 46 per 1000
(23 to 88)
OR 0.31
(0.15 to 0.62)
421
(3 studies)
low
5,6
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5
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6
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Cutting trocar compared to Blunt trocars for women undergoing laparoscopy
Patient or population: Women undergoing laparoscopy
Settings: Surgical
Intervention: Cutting trocar
Comparison: Blunt trocars
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Blunt trocars Cutting trocar
Major outcome - Vis-
ceral injury
0 per 1000 0 per 1000
(0 to 0)
OR 3.15
(0.13 to 78.43)
165
(1 study)
very low
1,2,3
71 per 1000 24 per 1000
(6 to 96)
OR 0.32
(0.08 to 1.39)
195
(2 studies)
moderate
1
Wound infection
0 per 1000 0 per 1000
(0 to 0)
OR 3.15
(0.13 to 78.43)
165
(1 study)
very low
1,2,3
Gas leak events
107 per 1000 136 per 1000
(58 to 286)
OR 1.31
(0.51 to 3.35)
165
(1 study)
low
1,3
1
Lacked an adequate explanation on randomisation, allocation concealment and blinding
2
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Transfundal insertion of the Veress Needle compared to Infra-umbilical insertion of the Veress Needle for women undergoing laparoscopy
Settings: Surgical
Intervention: Transfundal insertion of the Veress Needle
Comparison: Infra-umbilical insertion of the Veress Needle
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Infra-umbilical insertion
of the Veress Needle
Transfundal insertion of
the Veress Needle
Uterine bleeding
0 per 1000 0 per 1000
(0 to 0)
OR 7.7
(0.78 to 75.76)
100
(1 study)
very low
1,2,3
Failed entry
20 per 1000 3 per 1000
(0 to 122)
OR 0.14
(0 to 6.82)
100
(1 study)
very low
1,2,3
1
Lacked adequate information on blinding
2
3
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Lifting the abdominal wall before Veress Needle insertion compared to not lifting the abdominal wall before Veress Needle insertion for women undergoing laparoscopy
Settings: Surgical
Intervention: Lifting the abdominal wall before Veress Needle insertion
Comparison: Not lifting the abdominal wall before Veress Needle insertion
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Not lifting the abdominal
wall before Veress Nee-
dle insertion
Lifting the abdominal
wall before Veress Nee-
dle insertion
Visceral injury
See comment See comment Not estimable 150
(1 study)
See comment No events recorded
tion
13 per 1000 55 per 1000
(13 to 209)
OR 4.43
(0.98 to 20.1)
150
(1 study)
low
1,2
Failed entry
120 per 1000 377 per 1000
(228 to 555)
OR 4.44
(2.16 to 9.13)
150
(1 study)
low
1,2
1
Lacked adequate explanation of randomisation, allocation concealment and blinding
2
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Carbon dioxide gas insufflation compared to The use of a gasless abdominal wall retractor for women undergoing laparoscopy
Settings: Surgical
Intervention: Carbon dioxide gas insufflation
Comparison: The use of a gasless abdominal wall retractor
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
The use of a gasless ab-
dominal wall retractor
Carbon dioxide gas in-
sufflation
Vascular injury
0 per 1000 0 per 1000
(0 to 0)
OR 7.23
(0.45 to 115.64)
186
(2 studies)
low
1,2
tion
0 per 1000 0 per 1000
(0 to 0)
OR 7.58
(0.77 to 74.97)
83
(1 study)
very low
1,2,3
Trocar site haematoma
20 per 1000 3 per 1000
(0 to 118)
OR 0.13
(0 to 6.69)
103
(1 study)
very low
1,2,3
Wound infection
24 per 1000 24 per 1000
(1 to 284)
OR 0.98
(0.06 to 15.87)
83
(1 study)
low
1,3
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A closed technique compared to a parallel technique of Veress Needle insertion for women undergoing laparoscopy
Settings: Surgical
Intervention: A closed technique
Comparison: A parallel technique of Veress Needle insertion
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
A parallel technique of
Veress Needle insertion
A closed technique
Vascular injury
(1 study)
low
1,2
No events recorded
Visceral injury
(1 study)
low
1,2
No events recorded
tion
(1 study)
low
1,2
No events recorded
1
Lacked adequate explanation of randomisation and allocation concealment
2
3
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5 mm secondary port trocars compared to 3 mm secondary port trocars for women undergoing laparoscopy
Settings: Surgical
Intervention: 5 mm secondary port trocars
Comparison: 3 mm secondary port trocars
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
3 mm secondary port
trocars
5 mm secondary port
trocars
38 per 1000 5 per 1000
(0 to 81)
OR 0.14
(0.01 to 2.24)
102
(1 study)
very low
1,2,3
1
Lacked adequate explanation of allocation concealment
2
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3
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Radially expanding (STEP) secondary trocars compared to Standard secondary trocars for women undergoing laparoscopy
Settings: Surgical
Intervention: Radially expanding (STEP) secondary trocars
Comparison: Standard secondary trocars
(95% CI)
No of Participants
(studies)
(GRADE)
Comments
Standard secondary tro-
cars
Ra-
dially expanding (STEP)
secondary trocars
118 per 1000 16 per 1000
(3 to 110)
OR 0.12
(0.02 to 0.92)
68
(1 study)
moderate
1
65 per 1000 10 per 1000
(1 to 133)
OR 0.14
(0.01 to 2.21)
61
(1 study)
very low
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1
2
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D I S C U S S I O N
Summary of main results
Meta-analysis demonstrated no advantage of using an open or
closed entry technique in terms of reduction of vascular or visceral
complications.
However, there was a reduction in the incidence of failed entry
with the use of an open-entry technique compared to the Veress
Needle.
There was evidence of an advantage of using a direct-entry tech-
nique when compared to Veress-Needle entry in terms of failed
entry, extraperitoneal insufation, and omental injury.
There is no evidence to suggest that radially expanding trocars
are more or less safe in terms of reducing major complications
during either primary or secondary port placement. However, a
signicant reduction in trocar site bleeding was noted with their
use.
A signicant difference in trocar site bleeding was demonstrated
favouring the use of STEP trocars for primary port and secondary
port entry in comparison to standard trocars. This nding may
require some caution in interpretation due to substantial hetero-
geneity in one of the analyses (I
2
= 60%). However, the direction
of effect was consistent.
A single RCT suggests that lifting the abdominal wall for place-
ment of a Veress Needle increases the risks of failed entry, and no
advantage was noted in terms of vascular or visceral complications.
No signicant difference in minor or major complications was
demonstrated in the comparisons cutting versus blunt trocars and
SILS versus the standard Hassan technique.
Overall completeness and applicability of
evidence
Open versus closed-entry technique (primary port entry)
The technique of establishing pneumoperitoneum through the
Veress Needle is the most popular technique in gynaecological
laparoscopy. Its wide applicationcanbe attributed to its traditional
popularity and the lack of evidence to suggest otherwise. General
surgeons have embraced the open method of entry and suggest
that it is safer than closed laparoscopy with little evidence to back
their assertion (Crist 1993; Wolfe 1991).
It must be noted that the included RCTs had insufcient power
to effectively demonstrate an advantage. None of the studies that
compared these two interventions undertook a power calculation,
which may have contributed to inconclusive results (Akbar 2008;
Bemelman 1 2000; Cogliandolo 1998). However, previous retro-
spective studies (Ballem 1993; Fitzgibbons 1991; Sigman 1993)
have reported that an open technique to establish pneumoperi-
toneum is safer than the blind technique, with the avoidance of
both visceral and major vascular injury.
Gynaecologists have a variable denition for failed entry. Akbar
2008 dened failed entry as the failure of aspiration following
Veress Needle insertion on three consecutive attempts. Authors
reported a high rate of failed entry within the Veress Needle group
(11.4%).
These results need to be interpreted with caution as patients with a
midline laparotomy scar and a body weight of less than 40 kg were
excluded from the Bemelman 1 2000 study and Akbar 2008 ex-
cluded patients with previous upper abdominal surgery and para-
umbilical hernia.
Direct-trocar entry versus Veress Needle entry (primary port
entry)
Direct-trocar placement and Veress Needle insertionare blind pro-
cedures with the potential for major injury. The low incidence
of major complications at entry would require a large number of
patients to be included in the study and Garry 1999 concluded
that 828,204 patients would be required to show a reduction in
bowel-injury rate from 0.3% to 0.2% (Molloy 2002). It must be
noted that the included RCTs had insufcient power to effectively
demonstrate an advantage. All studies comparing the above inter-
ventions, except Agresta 2004, failed to undertake a power calcu-
lation. Unfortunately, the power calculation in Agresta 2004 was
upon the incidence rate of failed entry (12%), which is substan-
tially higher than other intra-operative and post-operative com-
plications, such as vascular injury (0.09%).
Several studies reported higher complication rates within the Ver-
ess Needle group. No randomised controlled trials have been iden-
tied which compare different operative techniques with regards
to inserting the Veress Needle. As the studies included within this
systematic reviewfail to universally state the precise operative tech-
nique deployed for insertion of the Veress Needle, no conclusions
can be made for the optimal method of insertion. This may con-
tribute to the results of the systematic review favouring direct tro-
car entry technique with regards to failed entry and extraperitoneal
insufation. The implications of failed entry within the studies
were either conversion to the alternate open technique or were not
clearly described.
It is also difcult to interpret the result in the context of the general
population, as several studies excluded patients based upon previ-
ous abdominal surgery (Agresta 2004; Bemelman1 2000; Borgatta
1990; Tansatit 1 2006) and obesity (Agresta 2004; Borgatta 1990).
Gunec 2005; Byron 1993 and Zakerah 2010 did not state exclu-
sion criteria. Byron 1993 concluded that neither direct-trocar nor
Veress Needle entry should be used in patients at risk of subum-
bilical adhesions, instead favouring an open technique in these
individuals.
The improper placement of gas, resulting in extraperitoneal in-
sufation, may result in failed laparoscopy and the need for la-
parotomy (Franks 1987). A further serious complication of ex-
traperitoneal insufation is the risk of gas embolism. Mintz 1977
reported no cases of gas embolism in 16,739 procedures involving
direct trocar, whereas three deaths were attributable to gas em-
bolism in an equivalent Veress Needle group.
Radially expanding (STEP) trocars versus standard trocars
The radially expanding access system (STEP TM, Inner Dyne,
Sunnyvale, California, USA) was developed to minimise tissue
trauma. This systemuses a pneumoperitoneumneedle with a poly-
meric sleeve. Following routine insufation the needle is removed,
leaving the outer sleeve in situ. Direct dilatation of the sleeve re-
sults in creation of a port. The suggested benets are that less tis-
sue trauma occurs and possibly fewer bowel and vascular injuries
occur (Ternamian 1997; Ternamian 1998).
As the dilator and cannula in the STEP device radially expands
the tissue tract created by the Veress Needle, the defects in the
abdominal wall are about 50% narrower and the incidence of
trocar site bleeding is considerably less withSTEPuse (Feste 2000).
In addition, the STEP device separates rather than cuts the tissue,
leaving a slit-like defect that forms along the muscle bres, as
opposed to the clover-leaf defect left by the cutting styles of a
conventional trocar (Bhoyrul 2000).
Lifting or not lifting the abdominal wall before Veress Needle
insertion (primary port entry)
Abdominal wall lifting is aimed at increasing skin resistance to fa-
cilitate cutaneous perforation with the Veress Needle. The RCOG
currently recommends stabilising the lower abdominal wall when
inserting the Veress Needle perpendicular to the skin incision
(RCOG 2008).
Analysis demonstratedanincreasedrisk of failedentry inthe lifting
group as compared to not lifting (Briel 2000). The result needs to
be interpreted with caution as failed entry has been dened as a
single attempt. This is not consistent with routine practice, which
classies failed entry after two attempts of Veress Needle insertion
(RCOG 2008).
Cutting versus blunt trocar (secondary port entry)
The perceived advantage of using blunt trocars is to provide greater
xity to the abdominal wall, therefore lowering the number of
spontaneous port dislodgements during surgery; this design fea-
ture would be unlikely to contribute to improved safety outcomes.
SILS versus classic laparoscopic for port entry (primary port
entry)
Although Tsimoyiannis 2009 demonstrated a signicant reduc-
tion in pain with the use of the SILS technique in comparison
to classic laparoscopic four port entry, no complications were re-
ported. There is a limited evidence base regarding the safety of
SILS and its use is predominantly being driven by industry.
The majority of the included studies were not blinded. Blinding
of the surgeon is clearly not possible in these studies and this
is unlikely to have affected the intra-operative events. However,
blinding couldbe important whenassessing delayedpost-operative
complications, such as pain and scarring, but these outcomes were
not considered in this systematic review.
The power calculation in Agresta 2004 estimated the requirement
of 230 patients to be recruited to each treatment arm. This is
unrealistic as a 12% estimated complication rate is much higher
than other estimates, which have been reported to vary between
1.0/1000 and 12.5/1000 for all complications (RCOG 2008).
Bisgaard 2007; Tsimoyiannis 2009 and Venkatesh 2007 under-
took a power calculation to assess the number required to detect
a minimal relevant difference in pain scores in the two surgical
groups, as opposed to complication rate. The low rate of reported
complications associated with laparoscopic entry and the small
number of participants within the included studies may account
for the lack of a signicant difference in terms of safety between
entry techniques. Results should be interpreted with caution for
outcomes where only single studies were included.
The potential for loss to follow-up is relevant within this system-
atic review with regards to delayed recognition of bowel injury
and minor complications, for example wound infection, follow-
ing discharge of the participants. However, Bemelman 1 2000 (2);
Feste 2000 (2) and Schulze 1999 (5) reported patients as losses to
follow-up because of intra-operative complications that required
conversion to a different technique, and therefore an intention-
to-treat analysis may have been of value.
Potential biases in the review process
Several outcomes reported within this review are variable with re-
spect to their denition, for example failed entry, wound infection
and trocar site bleeding. There is no universally agreed denition
of failed entry; study denitions have ranged from two to three
attempts of Veress Needle insertion before abandoning the pro-
cedure or converting to a different entry technique. Studies also
differ as to the methods used to conrm the correct placement of
the Veress Needle; some clinicians use a saline test and others may
use ow of gas and pressure within the cavity.
Twelve of the trials included within the review did not measure
the complication rate as a primary outcome; therefore authors did
not pre-dene the complications that would be measured and the
methodology of doing so. None of the included studies dened
the method of identifying wound infections, for example clinical
diagnoses or microbiological conrmation. Also, if the power cal-
culation was based upon the reduction in reported complication
rates, a larger number of participants would be required to pro-
duce signicant results.
Aprevious version of this reviewexcluded studies investigating the
use of secondary port insertion; these studies have been included
withinthis updated version. Inthis version of the review, the newly
included studies have been re-assessed to ensure they meet the
inclusion criteria. They have been assessed for risk of bias.
Agreements and disagreements with other
studies or reviews
The Royal College of Obstetrics and Gynaecology guidelines cur-
rently do not recommend a specic laparoscopic entry technique.
However, for extremes of BMI they recommend open entry (Has-
son) technique. This review has not demonstrated any major sa-
fety advantage with the use of either an open or closed-entry tech-
nique; however, this review was not designed to specically iden-
tify the preferred entry technique for women at extremes of BMI
(RCOG 2008).
The results of the systematic review agree with the results of two
other reviews of randomised and non-randomised data (Merlin
2003; Molloy 2002).
A U T H O R S C O N C L U S I O N S
Implications for practice
The open-entry technique is associatedwitha signicant reduction
in failed entry when compared to the closed-entry technique, with
no difference in the incidence of visceral or vascular injury.
Signicant benets were noted with the use of the direct-entry
technique when compared to the Veress Needle. The use of the
Veress Needle was associated with an increased incidence of failed
entry, extraperitoneal insufation and omental injury; direct-tro-
car entry is therefore a safer closed-entry technique.
The low rate of reported complications associated with laparo-
scopic entry and the small number of participants within the in-
cluded studies may account for the lack of signicant difference
in terms of major vascular and visceral injury between entry tech-
niques. Results should be interpreted with caution for outcomes
where only single studies were included.
Implications for research
Randomised controlled trials of adequate power are required to
detect a signicant reduction in risks of major complications. Fur-
ther well designed randomised controlled trials are required to de-
termine the optimal entry technique in patients with extreme BMI
and those with previous abdominal and pelvic surgery.
A C K N O W L E D G E M E N T S
We acknowledge Dr Birgit Luehr, who translated several papers.
We would like to thank the members of the Cochrane Menstrual
Disorders and Subfertility ReviewGroup, based in Auckland, New
Zealand, who assisted with this review.
R E F E R E N C E S
References to studies included in this review
Agresta 2004 {published data only}
Agresta F, DeSimone P, Ciardo LF, Bedin N. Direct

trocar insertion versus Veress needle in non obese patients
undergoing laparoscopic procedures. Surgical Endoscopy
2004;18:177881.
Akbar 2008 {published data only}
Akbar M, Khan IA, Naveed D, Khattak I, Zafar A, Wazir
MS, et al.Comparison of closed and open methods of
pneumoperitoneum in laparoscopic cholecystectomy. The
Journal of Ayub Medical College Abbottabad 2008;20(2):
859.
Bemelman 1 2000 {published data only}
Bemelman WA, Dunker MS, Busch ORC, Den Boer KT,

De Wit LTH, Gouma DJ. Efcacy of establishment of
pneumoperitoneum with the Veress Needle, Hasson trocar,
and modied blunt trocar (TrocDoc): A Randomized
Study. Journal of Laparoendoscopic and Advanced Surgical
Techniques 2000;10(6):32530.
Bemelman 2 2000 {published data only}
Bemelman WA, Dunker MS, Busch ORC, Den Boer
KT, De Wit LTH, Gouma DJ. Efcacy of establishment
of pneumoperitoneum with the Veress Needle, Hasson
trocar, and modied blunt trocar (TrocDoc): a randomized
study. Journal of Laparoendoscopic and Advanced Surgical
Techniques 2000;10(6):32530.
Bemelmen 3 2000 {published data only}
Bemelman WA, Dunker MS, Busch ORC, Den Boer KT,
De Wit LTH, Gouma DJ. Efcacy of establishment of
pneumoperitoneum with the Veress needle, Hasson trocar,
and modied blunt trocar (TrocDoc): a randomized study.
Journal of Laparoendoscopic and Advanced Surgical Techniques
2000;10(6):32530.
Bhoyrul 2000 {published data only}
Bhoyrul S, Payne J, Steffes B, Swanstrom L, Way LW. A
randomized prospective study of radially expanding trocars
in laparoscopic surgery. Journal of Gastrointestinal Surgery
2000;4(4):3927.
Bisgaard 2007 {published data only}
Bisgaard T, Jakobsen HL, Jacobsen B, Olsen SD, Rosenberg
J. Randomized clinical trial comparing radially expanding
trocars with conventional cutting trocars for the effects on
pain after laparoscopic cholecystectomy. Surgical Endoscopy
2007;21:20126.
Borgatta 1990 {published data only}
Borgatta L, Gruss L, Barad D, Kaali SG. Direct trocar
Insertion vs. Veress Needle use for laparoscopic sterilization.
The Journal of Reproductive Medicine 1990;35(9):8914.
Briel 2000 {published data only}
Briel JW, Plaisier PW, Meijer WS, Lange JF. Is it
necessary to lift the abdominal wall when preparing a
pneumoperitoneum?. Surgical Endoscopy 2000;14:8624.
Byron 1993 {published data only}
Byron JW, Markenson G, Miyazawa K. A randomized
comparison of Veress needle and direct trocar insertion for
laparoscopy. Surgery 1993;177:25962.
Cogliandolo 1998 {published data only}
Cogliandolo A, Manganaro T, Saitta FP, Micali B. Blind
versus open approach to laparoscopic cholecystectomy.
Surgical Laparoscopy and Endoscopy 1998;8(5):3535.
Cravello 1999 {published data only}
Cravello L, DErcole C, Roger V, Samson D, Blanc
B. Laparoscopic surgery in gynaecology: randomized
prospective study comparing pneumoperitoneum and
abdominal wall suspension. European Journal of Obstetrics,
Gynecology, and Reproductive Biology 1999;83:914.
Feste 2000 {published data only}
Feste JR, Bojahr B, Turner DJ. Randomized trial comparing
a radially expandable needle system with cutting trocars.
Journal of the Society of Laparoendoscopic Surgeons 2000;4:
115.
Ghezzi 2005 {published data only}
Ghezzi F, Cromi A, Colombo G, Uccella S, Bergamini
V, Serati M, et al.Minimizing ancillary ports size in
gynaecologic laparoscopy: A randomized trial. The Journal
of Minimally Invasive Gynaecology 2005;12:4805.
Gunec 2005 {published data only}
Gunec MZ, Yesildaglar N, Bingol B, Onalan G, Tabak S,
Gokmen B. The safety and efcacy of direct trocar insertion
with elevation of the rectus sheath instead of the skin for
pneumoperitoneum. Surgical Laparoscopy, Endoscopy &
Percutaneous Techniques 2005;15(2):801.
Hamade 2007 {published data only}
Hamade AM, Issa ME, Haylett KR, Ammori BJ. Fixity of
ports to the abdominal wall during laparoscopic surgery:a
randomized comparison of cutting versus blunt trocars.
Surgical Endoscopy 2007;21:9659.
Johnson 1997 {published data only}
Johnson PL, Sibert KS. Laparoscopy: gasless vs. CO2
pneumoperitoneum. The Journal of Reproductive Medicine
1997;42(5):2559.
Kitano 1993 {published data only}
Kitano S, Iso Y, Tomikawa M, Moriyama M, Sugimachi K. A
prospective randomized trial comparing pneumoperitoneum
and U-shaped retractor elevation for laparoscopic
cholecystectomy. Surgical Endoscopy 1993;7:3114.
Lam 2000 {published data only}
Lam TY, Lee SW, Frcs H, Kwok, P. Radially expanding
trocar: a less painful alternative for laparoscopic surgery.
Journal of Laparoendoscopic & Advanced Surgical Techniques
2000;10(5):26973.
Mettle 2000 {published data only}
Mettler L, Maher P. Investigation of the effectiveness of the
radially-expanding needle system, in contrast to the cutting
trocar in enhancing patient recovery. Minimally Invasive
Therapy and Allied Technologies 2000;9(6):397401.
Minervini 2008 {published data only}
Minervini A, Davenport K, Pefanis G, Keeley Jr FK,
Timoney AG. Prospective study comparing the bladeless
optical access versus hasson open trocar for the establishment
of pneumoperitoneum in laparoscopic renal procedures.
Archivo Italiano di Urologia e Andrologia 2008;80(3):958.
Ostrzenski 1999 {published data only}
Ostrzenski A. Randomized, prospective, single-blind trial
of a new parallel technique of Veress pneumoperitoneum
needle insertion versus the conventional closed method.
Fertility and Sterility 1999;71(3):57881.
Santala 1999 {published data only}
Santala M, Jarvela I, Kauppila A. Transfundal insertion of a
Veress needle in laparoscopy of obese subjects: a practical
alternative. Human Reproduction 1999;14(9):22778.
Schulze 1999 {published data only}
Schulze S, Lyng KM, Bugge K, Perner A, Bendtsen A,
Thorup J, et al.Cardiovascular and respiratory changes and
convalescence in laparoscopic colonic surgery. Archives of
Surgery 1999;134:11128.
Tansatit 1 2006 {published data only}
Tansatit T, Wisawasukmongchol W, Bunyavejchevin S. A
randomized, prospective study comparing the use of the
missile trocar and the pyramidal trocar for laparoscopy
access. Journal of The Medical Association of Thailand 2006;
89(7):9417.
89(7):9417.
89(7):9417.
Tinelli 2010 {published data only}
TInelli A, Malvasi A, Istre O, Keckstein J, Stark M, Mettler
L. Abdominal access in gynaecological laparoscopy: a
comparison between direct optical and blind closed access
by Veress needle. European Journal of Obstetrics, Gynecology,
and Reproductive Biology 2010;148:1914.
Tsimoyiannis 2009 {published data only}
Tsimoyiannis EC, Konstantinos TE, Pappas-Gogos G,
Farantos C. Different pain scores in single trans umbilical
incision laparoscopic cholecystectomy versus classic
laparoscopic cholecystectomy:a randomized controlled trial.
Surgical Endoscopy 2010;24:18428.
Venkatesh 2007 {published data only}
Venkatesh R, Sundaram CP, Figenshau RS, Yan Yan,
Andriole GL, Clayman RV, Landman J. Prospective
randomized comparison of cutting and dilating disposable
trocars for access during laparoscopic renal surgery. JSLS:
Journal of the Society of Laparoendoscopic Surgeons 2007;11:
198203.
Yim 2001 {published data only}
Yim SF, Yuen PM. Randomized double-masked comparison
of radially expanding access device and conventional cutting
tip trocar in laparoscopy. Obstetrics and Gynecology 2001;97
(3):4358.
Zakerah 2010 {published data only}
Zakherah MS. Direct trocar versus Veress Needle entry for
laparoscopy: A randomized clinical trial. Gynecologic and
Obstetric Investigation 2010;69:2603.
References to studies excluded from this review
Joshipura 2009 {published data only}
Joshipura VP, Haribhakti SP, Patel NR, Naik RP, Soni
HN, Patel B, et al.A prospective randomized, controlled
study comparing low pressure versus high pressure
pneumoperitoneum during laparoscopic cholecystectomy.
Surgical Laparoscopy, Endoscopy & Percutaneous Techniques
2009;19(3):23440.
Kim 2009 {published data only}
Kim SS, Kim SH, Mun SP. Should subcostal and lateral
trocars be used in laproscopic cholecystectomy? A
randomized, prospective study. Journal of Laparoendoscopic
& Advanced Surgical Techniques 2009;19:6.
Sandhu 2009 {published data only}
Sandhu T, Yamada S, Ariyakachn V, Chakrabandhu
T, Chongrukust W, Ko-iam W. Low-pressure
pneumoperitoneum versus standard pneumoperitoneum
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References to other published versions of this review
Ahmad 2008
Ahmad G, Duffy JMN, Phillips K, Watson A. Laparoscopic
Entry Techniques. Cochrane Database of Systematic Reviews
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Indicates the major publication for the study

C H A R A C T E R I S T I C S O F S T U D I E S
Characteristics of included studies [ordered by study ID]
Agresta 2004
Methods Randomised controlled trial.
Participants Non-obese paediatric and adult patients referred for urgent or scheduled laparoscopic
and gynaecologic procedures. 275 in the direct trocar group and 323 in the Veress needle
group. No patients lost to follow up. Exclusion criteria based upon BMI>27, presence
of massive bowel distension, and history of 2 or more abdominal operations. Power
calculation made
Interventions Veress needle (technique unclear) insertion versus direct trocar insertion (zero degree
tilt on the table, umbilical incision, shielded trocars) . No co-intervention. Standardised
operative training in both interventions especially for the study. Standardised operative
technique was deployed by all operators
Outcomes Aim: Assessing technical feasibility and safety. Reported primary complications includ-
ing mortality, visceral and solid organ injury and secondary complications including
extraperitoneal insufation, failed entry, and gas embolism
Notes Single centre at Veneto, Italy
Risk of bias
Bias Authors judgement Support for judgement
Random sequence generation (selection
bias)
Unclear risk Method of randomisation unclear.
Allocation concealment (selection bias) Low risk Because of an 8% post hoc deviation of patient alloca-
tion due to the sealed-envelope randomization method
adopted, the level of signicance was set at 0.01.
Blinding (performance bias and detection
bias)
All outcomes
Unclear risk Unclear, no reference made.
Incomplete outcome data (attrition bias)
All outcomes
Low risk No loss to follow up or exclusions reported.
Selective reporting (reporting bias) Low risk Data was presented as number of cases and percentages;
no conversionof data. Pvalues stated as NS for outcomes
as opposed to actual value. No omission of outcomes
and no subsets of data. Power calculation performed
Other bias Low risk No other bias identied.
Akbar 2008
Participants Patients with symptomatic gallstones with normal common bile duct scheduled for
laparoscopic cholecystectomy were included. Exclusion criteria based upon patients with
paraumbilical hernia, history of upper abdominal surgery and uncontrolled systemic
illness
Interventions In group A pneumoperitoneum was created by closed method (infra umbilical transverse
incision, Veress needle) compared to open method in group B (supra umbilical incision)
No co-intervention. Standardised operative approach
Outcomes Assessing hospital stay, operating time and complications. Injury during induction, fail-
ure of technique and port site infection were reported
Notes
Risk of bias
bias)
Unclear risk Selected patients were randomised into group A and
B using sealed envelopes containing questionnaire. Sev-
enty ProForma, 35 for each group were prepared and
sealed in blank envelopes. Each envelope contained one
out of these seventy ProForma. After informed consent,
an envelope was randomly fetched and opened.
Allocation concealment (selection bias) Low risk Selected patients were randomised into group A and
B using sealed envelopes containing questionnaire. Sev-
enty ProForma, 35 for each group were prepared and
sealed in blank envelopes. Each envelope contained one
out of these seventy ProForma. After informed consent,
an envelope was randomly fetched and opened.
bias)
All outcomes
Unclear risk All the patients were operated upon under general
anaesthesia by the same anaesthesia team. The surgical
team consisted of a surgeon (principal author), two as-
sistants and one scrub nurse.
All outcomes
Unclear risk No loss to follow up or lost data reported. However,
some participants excluded if operation converted to
open cholecystectomy- gures not given
Selective reporting (reporting bias) Low risk No power calculation; therefore power calculation set
as 33%. Data was presented as number of cases and
percentages; no conversion of data. P values stated for
outcome. No omission of outcomes and no subsets of
data.
Akbar 2008 (Continued)
Other bias Low risk
Bemelman 1 2000
Methods Randomised controlled trial which was single-blinded, with three arms. Patients pre-
senting between June and December 1999, duration 7 months
Participants 62 patients eligible for laparoscopic surgery were enrolled in the study. Exclusion criteria
was based upon age <18 years old, prior midline laparotomy or laparoscopy and body
weight <40 kg. Exclusion criteria not based upon age, sex and procedures preformed.
20 participants in the Veress needle group, 20 in the Hasson trocar group and 20 in the
Modied Blunt trocar (TrocDoc) group. Two lost to follow-up
Interventions Hasson trocars versus Direct trocar. No co-intervention. Standardised operative training
in both interventions especially for the study. Standardised operative technique was
deployed by all operators
Outcomes Aim: Assessing technical feasibility. Reported the patient mortality as an outcome
Notes Single centre at Amsterdam, the Netherlands.
Risk of bias
bias)
Allocation concealment (selection bias) Low risk After informed consent was obtained, the
sealed envelope method was used to reveal
the method of establishment of the pneu-
moperitoneumfor that patient after induc-
tion of anesthesia. Patients were thereby
randomly allocated into three groups
bias)
All outcomes
Unclear risk Not stated.
All outcomes
Unclear risk Reported patients as lost to follow up be-
cause of intra-operative complications,
which required conversion to a different
technique, and therefore an intention-to-
treat analysis may have been of value
Two patients were withdrawn from inclu-
sion during surgery, and no time-motion
analysis was performed
Bemelman 1 2000 (Continued)
Selective reporting (reporting bias) Low risk Data was presented as number of cases; no
conversion of data. P values stated for out-
come. No omission of outcomes and no
subsets of data.
Bemelman 2 2000
Participants Patients presenting between June and December 1999, 62 patients eligible for laparo-
scopic surgery were enrolled in the study. Exclusion criteria was based upon age <18
years old, prior midline laparotomy or laparoscopy and body weight <40 kg. Exclusion
criteria not based upon age, sex and procedures preformed
Interventions Hasson trocars (inserted through semi-circular sub-umbilical incision and abdominal
fascia was incised between the sutures) versus Veress needle (Semi-circular subumbilical
incision, needle inserted vertically to the incision and pneumoperitoneum achieved at
intra-abdominal pressure of 15 mmHg before placement of needle). No co-intervention.
Standardised operative training in both interventions especially for the study. Standard-
ised operative technique was deployed by all operators
Outcomes Aim: Assessing Technical feasibility. Reported the patient mortality as an outcome
Notes
Risk of bias
bias)
bias)
All outcomes
Bemelman 2 2000 (Continued)
All outcomes
subsets of data
Bemelmen 3 2000
Participants Patients presenting between June and December 1999, 62 patients eligible for laparo-
scopic surgery were enrolled in the study. Exclusion criteria was based upon age <18
years old, prior midline laparotomy or laparoscopy and body weight <40 kg. Exclusion
criteria not based upon age, sex and procedures performed
Interventions Direct trocar versus Veress Needle. No co-intervention. Standardised operative training
in both interventions especially for the study. Standardised operative technique was
deployed by all operators
Outcomes Aim: Assessing technical feasibility. Reported the patient mortality as an outcome
Notes
Risk of bias
bias)
Bemelmen 3 2000 (Continued)
bias)
All outcomes
All outcomes
subsets of data
Bhoyrul 2000
Methods Randomised controlled trial which was double-blinded.
Participants All adult patients under the care of the 16 participating laparoscopic general surgeons.
Exclusion criteria based upon acute inammatory conditions and conversion to laparo-
tomy not due to an entry complication. Exclusion criteria was not base upon age, sex or
type of procedure. 119 participants in the radially expanding (STEP) trocar group and
125 in the Veress needle group. None lost to follow-up
Interventions Radially expanding (STEP) (technique unclear) trocars versus standard trocars (tech-
nique unclear). No co-intervention. Standardised operative technique was deployed by
all operators
Outcomes Aim: Assessing safety. Reported primary complications including vascular, visceral and
solid organ injury and secondary complications including incisional hernias and wound
site bleeding
Notes Single centre at San Francisco, USA.
Risk of bias
bias)
Low risk Randomizationwas determined fromran-
domization tables before patient enrol-
ment
was begun.
Bhoyrul 2000 (Continued)
Allocation concealment (selection bias) Unclear risk Allocation concealment not referred to.
bias)
All outcomes
Low risk Double blinded - participants and ob-
servers. Patients and postoperative ob-
servers were blinded to the choice of trocar
used in the operations.
All outcomes
Low risk Five participants converted to laparo-
tomy One participant who originally
consented to participate and later refused
was removed from the study
Selective reporting (reporting bias) Low risk Data was presented as number of cases and
percentages; no conversionof data. Pvalues
stated for outcome. No omission of out-
comes and no subsets of data. Power calcu-
lation performed
Bisgaard 2007
Participants Participants undergoing elective cholecystectomy were enrolled within the study. The
criteria of exclusion specied ASA physical class 4, age younger than 18 and older than
75 years, and pregnancy. Patients with postoperative complications were included in the
analysis. Patients were not invited to participate in the study if they had chronic pain
diseases other than gallstone disease, if they received opioids or tranquillizers (treatment
for more than 1 week before laparoscopic cholecystectomy), if they spoke a foreign
language, if they had a mental disorder, or if they had a history of alcohol or drug abuse.
Patients were excluded from the study (study data were not collected) if the operation
was converted from a laparoscopic to an open procedure. 39 participants in cutting
group and 38 in radial group.Three participants excluded
Interventions Laparoscopic cholecystectomy was performed using two 10-mm and two 5-mm tro-
cars. In the radially expanding group (radial group), the four trocars comprised the Ver-
saStep system (Auto Suture, Radially Expanding Access [REA] system; Tyco Healthcare,
Copenhagen), and in the conventional cutting group (cutting group), the four trocars
were cutting bladed trocars (Endopath II; Ethicon Endosurgery, Inc., Cincinnati). Stan-
dardised general anaesthesia and analgesia. Standardised operative technique performed
or supervised by experienced surgeons
Outcomes Primary outcome of study was incisional pain, pain 6 hours after the operation and post
operative pain and days 1 and 2. Secondary outcomes included need for fascial incision,
active surgical haemostasis, supplementary need for opioids, moderate or severe nausea
and suggilations at trocar site
Bisgaard 2007 (Continued)
Notes Single-centre trial at university hospital, Denmark.
Risk of bias
bias)
Low risk Patients were consecutively enrolledinthe trial by the
medical staff inthe surgical unit several days before the
operation. After induction of anaesthesia, the surgeon
randomised the patients to laparoscopic cholecystec-
tomy using radially expanding trocars (radial group)
or conventional cutting trocars (cutting group) by the
sealed envelope method based on a block-randomised
computer-generated list.
Allocation concealment (selection bias) Low risk Patients were consecutively enrolledinthe trial by the
medical staff inthe surgical unit several days before the
operation. After induction of anaesthesia, the surgeon
randomised the patients to laparoscopic cholecystec-
tomy using radially expanding trocars (radial group)
or conventional cutting trocars (cutting group) by the
sealed envelope method based on a block-randomised
computer-generated list.
bias)
All outcomes
Low risk The trial was patient- and observer-blinded. At the
end of the operation, the incisions were covered with
nontransparent standard dressings (5 5 cm), and the
patients were instructed to keep the dressings on for
the rst 2 postoperative days. The patient and the
surgical staff, including the nurses, were blinded to
the type of trocar used. The operating surgeon and
the anaesthesiologist in charge did not participate in
the postoperative assessment and did not attend to
the patients.
All outcomes
Unclear risk 3 exclusions from trial. One of the three excluded
patients underwent conversion to an open procedure
(radial group) and the remaining two patients (one
from each surgical group) had no study data available
due to loss of their study diary.
Selective reporting (reporting bias) Unclear risk P values not stated for some outcomes; i.e. moderate
and severe suggilations. Some data subgrouped; e.g.
little, moderate and severe suggilations. No omission
of outcome or selective use of data. No conversion of
data
Other bias Low risk No other risk of bias identied.
Borgatta 1990
Methods Randomised controlled trial which was single-blinded.
Participants Women undergoing elective laparoscopic sterilisation under general anaesthetic at an
out-of-hospital surgical unit. Exclusion criteria not stated. Exclusion was not made on
the basis of previous abdominal surgery (including Caesarean section), presence of intra-
abdominal adhesions, age, weight, height and parity. 110 in the Veress Needle group
and 102 in the direct trocar group. None lost to follow-up
Interventions Veress needle insertion (technique unclear) versus direct trocar insertion (technique un-
clear). No co-intervention
Outcomes Aim: Assessing technical feasibility and complications. Reported secondary complica-
tions including extraperitoneal insufation, omentum injury and wound site infection,
and failed entry
Notes Single centre at New York, USA.
Risk of bias
bias)
Unclear risk Method not explicitly stated assigned ran-
domly.
Allocation concealment (selection bias) Unclear risk Not referred to within paper.
bias)
All outcomes
Unclear risk Not referred to within paper.
All outcomes
Low risk No data issues identied.
Selective reporting (reporting bias) Low risk No reporting issues identied.
Other bias Low risk No evidence of additional bias.
Briel 2000
Participants 150 consecutive patients scheduled for laparoscopy. Exclusion criteria based upon pre-
vious abdominal surgery and obesity (BMI >40). Exclusion not based upon age or sex.
75 in the lifting group and 75 in the non-lifting group. None lost to follow-up
Interventions Lifting of the abdominal wall before Veress needle insertion (abdominal wall lifted using
two hands, the decision to re-insert the needle was made when the insufation pressure
was more than 10 mmHg) versus non-lifting (technique unclear). No co-intervention
Briel 2000 (Continued)
Outcomes Aim: Assessing technical feasibility and safety. Reported secondary complications includ-
ing extraperitoneal insufation and failed entry
Notes Single centre at Rotterdam, the Netherlands
Risk of bias
bias)
Unclear risk Method not stated but described as ran-
domised.
Allocation concealment (selection bias) Unclear risk Not referred to within the paper.
bias)
All outcomes
Unclear risk Not referred to within the paper.
All outcomes
Low risk No loss to follow-up or exclusions reported.
Selective reporting (reporting bias) Low risk Data were presented as number of cases;
no conversion of data. P values not stated
for failed entry but for all other outcomes.
No omission of outcomes and no subsets
of data. No power calculation performed
Other bias Low risk No other sources of bias identied.
Byron 1993
Methods Randomised controlled trial which was single-blinded between September 1988 and
June 1989. 10 months duration
Participants Patients presenting between September 1988 and June 1989.11 in the direct trocar group
and 275 in the Veress Needle group. None lost to follow-up
Interventions Veress needle insertion versus direct trocar insertion. No co-intervention. No standard-
ised operative technique or training stated
Outcomes Aim: Assessing technical feasibility and complications. Reported secondary complica-
tions including extraperitoneal insufation and also failed entry
Notes Single centre at Washington, USA.
Risk of bias
Byron 1993 (Continued)
bias)
Low risk Truly randomised - randomnumber tables.
bias)
All outcomes
Low risk Single blinded, patients only.
All outcomes
Low risk No incomplete data issues identied.
Selective reporting (reporting bias) Low risk No selective reporting issues identied.
Cogliandolo 1998
Participants 150 patients, aged 16 to 77, undergoing laparoscopic cholecystectomy. Inclusion or
exclusion criteria unspecied. 75 in the blind (Veress needle) group and 75 in the open
trocar (Hasson trocar) group. None lost to follow-up
Interventions Open (Veress needle) entry technique versus closed (Hasson trocar) entry technique. No
co-intervention. Standardised operative training in both interventions especially for the
study. Standardised operative technique was deployed by all operators. The technique of
pneumoperitoneum has not been specied, in terms of the use of pressure or volume of
gas for Veress Needle entry. Standard Hasson trocar entry
Outcomes Aim: Assessing technical feasibility and complications. Reported primary complications
including vascular and visceral injury and secondary complications including extraperi-
toneal insufation and wound site bleeding and infection
Notes Single centre at Messina, Italy.
Risk of bias
bias)
Low risk All patients were entered into two groups
according to a computerized randomnum-
ber selection.
Cogliandolo 1998 (Continued)
Allocation concealment (selection bias) Unclear risk All patients were entered into two groups
according to a computerized randomnum-
ber selection.
bias)
All outcomes
Unclear risk No blinding mentioned within study.
All outcomes
Low risk No exclusion or dropouts. However, three
cases converted to open surgery because
of difculty in recognising location of
anatomical structures and in two cases con-
version was due to major complications re-
lated to the introduction of the rst trocar
percentages; no conversion of data. P val-
ues stated for total major complications.
No omission of outcomes and no subsets
of data. No power calculation mentioned
Other bias Low risk No other selective bias issues identied.
Cravello 1999
Participants All patients, who were seen either on an outpatient basis or an emergency basis, presented
with an indication for laparoscopic surgery, were given the option to be included in the
trial. Patients with intra abdominal malignancy were excluded. 103 in insufation with
carbon dioxide gas group and. 51 in gasless abdominal wall retractor group
Interventions Laparoscopic surgery using insufation of carbon dioxide gas versus a gasless abdominal
wall retractor. No co-intervention. Standardised operative technique was deployed by all
operators
Outcomes Aim: Assessing technical feasibility and complications.
Notes
Risk of bias
bias)
Low risk Patients were randomized by a random
number table before the induction of anes-
thesia
Cravello 1999 (Continued)
Allocation concealment (selection bias) Unclear risk No reference to allocationconcealment was
made within the text of the paper
bias)
All outcomes
Unclear risk Absent.
All outcomes
Low risk 9 participants converted from gasless la-
paroscopy technique- reasons given for all
exclusions
not stated for each outcome. No omission
of outcomes and no subsets of data. Power
calculation not stated
Other bias Low risk No bias concerns identied.
Feste 2000
Participants Various operative and diagnostic laparoscopic procedure were performed by seven dif-
ferent surgeons on 87 consecutive women. Exclusion criteria not stated. Exclusion was
not based upon age and weight. There was a signicant difference in weight favouring
the STEP trocar group (higher). 45 in the Radially expanding (STEP) trocar group and
42 in the Veress needle group. None lost to follow-up
Interventions Radially expanding (STEP) trocars (technique not stated) versus standard trocars (tech-
nique not stated). No co-intervention
Outcomes Aim: Assessing safety. Reported primary complications including vascular and visceral
injury
Notes Multi-centre at Greifswald, Germany , Houston, USA, and Santa Barbara, USA
Risk of bias
bias)
Unclear risk Method of randomisation unclear. Pa-
tients were randomized to treatment
Feste 2000 (Continued)
bias)
All outcomes
Low risk Double blinded, patients and observer
only. Patients were blinded as to which
type of instrument was used A blinded,
trained observer assessed the operative
wounds
All outcomes
Unclear risk Reported patients as lost to follow-up as re-
quired conversion to a different technique
conversion of data. P values not stated for
each outcome. No omission of outcomes
and no subsets of data. Power calculation
not stated
Other bias Low risk No additional bias issues identied.
Ghezzi 2005
Methods Randomised controlled trial which was single-blinded from March 2004 and October
2004. 8 months duration. Both ports were inserted in the same patient with the side
inserted randomised
Participants Consecutive patients undergoing operative laparoscopy because of a suspected benign
adnexal mass at a university hospital from March 2004 through October 2004 were
enrolled in the study. Patients with intra-abdominal malignancy were excluded. 50 par-
ticipants in the 3mm trocar group and 52 in the 5mm trocar group for secondary port
entry.No patients lost to follow-up
Interventions 5mm trocars compared with 5mm trocar group for secondary port entry. No co-inter-
vention Standardised operative technique was reported
Outcomes Trocar site bleeding.
Notes Single centre trial at university hospital.
Risk of bias
bias)
Low risk Patients were randomised according to a
computer-generated list
bias)
All outcomes
Low risk Single blinded, patients only. The patients
were blinded with respect to the surgical
technique assignment
Ghezzi 2005 (Continued)
All outcomes
Low risk FIve exclusions. Five patients converted to
laparotomy- reasons stated
conversion of data. P values stated for each
outcome. No omission of outcomes and no
subsets of data. No power calculationstated
Other bias Low risk No sources of additional bias identied.
Gunec 2005
Participants Bothinclusionandexclusioncriteria were not stated. Authors writtentoofor clarication.
277participants in the direct trocar group and 301 in the Veress Needle group. None
lost to follow-up
Interventions Direct trocar (elevation of rectus sheath &12-13 mmtransfers subumbilical incision was
made through the sheath and the sheath was grasped and elevated using two towel clips)
versus Veress Needle (10 mm transverse umbilical incision, needle inserted pointing
towards the uterus and 10-15 mmHg intra-abdominal pressure used as a guide to place
the primary trocar). No co-intervention. Standardised operative technique was deployed
by all operators
Outcomes Aim: Assessing complication rates. Reported secondary complications including ex-
traperitoneal insufation and failed entry
Notes Single centre at Ankara, Turkey.
Risk of bias
bias)
Unclear risk Stated as randomised within the paper, ex-
act method not stated
Allocation concealment (selection bias) Unclear risk Allocation concealment not referred to
within the paper.
bias)
All outcomes
Unclear risk Blinding not referred to within paper.
All outcomes
Low risk No exclusions or loss to follow up stated.
Gunec 2005 (Continued)
subsets of data.
Other bias Low risk No other bias issues identied.
Hamade 2007
Methods Randomised controlled trial, which was single blinded.
Participants Adults under going elective laparoscopic surgery; aged 16-80 years. No other exclusion
criteria stated. 15 participants in cutting trocar group and 15 participants in the blunt
trocar group. No loss to follow-up
Interventions Primary port insertion was accomplished using direct a blunt-tipped trocar at a site
other than the umbilicus and without prior peritoneal insufation as we have previously
described. Secondary port insertion was then accomplished under direct laparoscopic
vision using either a reusable cutting metal trocar (Mantis Surgical Limited, Newbury,
Berkshire, UK), which had three sharp xed blades, or a reusable blunt-tipped metal
trocar (Mantis SurgicalLimited), which had a conical blunt tip. No co-intervention.
Standardised operative technique
Outcomes Aim: Port stability and tractionforces required at beginning and at completionof surgery.
Number of ports dislodged spontaneously and abdominal wall bleeding at trocar site
Notes Single-centre trial at Manchester Royal Inrmary, UK.
Risk of bias
bias)
Low risk A computer-generated randomisations list
was produced by an independent statisti-
cian and was opened by an independent
person who produced envelopes contain-
ing the number of the study patient and a
card labelled Blunt or Sharp. The en-
velopes were sealed and placed in the oper-
ating theatre
Allocation concealment (selection bias) Low risk A computer-generated randomisation list
was produced by an independent statisti-
cian and was opened by an independent
person who produced envelopes contain-
ing the number of the study patient and a
card labelled Blunt or Sharp. The en-
velopes were sealed and placed in the oper-
Hamade 2007 (Continued)
ating theatre
bias)
All outcomes
Unclear risk Not stated within study.
All outcomes
Low risk Complications not pre-dened by study;
however primary aimwas port stability and
friction forces. No loss to follow up or lost
data reported
Selective reporting (reporting bias) Low risk No conversion of data. P values stated for
and no subsets of data.
Other bias Low risk No other risk of bias identied.
Johnson 1997
Participants Women presenting for sterilisation and over the age of 21. Exclusion criteria was based
upon weight (more than 100% of their ideal body weight). Exclusion was not based
upon weight, height and prior abdominal or pelvic surgery. 10 patients were assigned
to the gasless laparoscopy group, while 8 were assigned to the CO2 laparoscopy group.
None lost to follow-up
Interventions Laparoscopic surgery using insufation of carbon dioxide gas (technique unclear) versus
a gasless abdominal wall retractor (technique unclear). No co-intervention. Standardised
operative training in both interventions especially for the study
Outcomes Aim: Assessing technical feasibility, ventilatory parameters, haemodynamic stability, and
post-operative pain and nausea. Did not report any outcome measures. Authors have
been written to. Outcome measures reported included ease of operative technique and
patient pain and nausea
Notes Single centre at North Carolina, USA.
Risk of bias
bias)
Low risk A randomization protocol consisting of a
randomization block design
Allocation concealment (selection bias) Unclear risk No reference to allocation concealment
made.
Johnson 1997 (Continued)
bias)
All outcomes
Low risk Single blinded, patients only. The sub-
jects were not informed of their treatment
group
All outcomes
Unclear risk No outcome measures reported; authors
have been written to for clarication. No
drop outs or exclusions stated
Selective reporting (reporting bias) Unclear risk Data was presented as number of cases; no
each outcome. Not all outcomes reported
not stated
Kitano 1993
Methods Randomised controlled trial which was single-blinded fromApril to August 1991. Study
duration of 5 months
Participants Patients referred for treatment of gallstones from April to Aug, 1991. Exclusion criteria
was based upon previous abdominal surgery, concomitant common bile duct stones and
gall bladder cancer. Exclusion was not based upon age and sex. 82 in the pneumoperi-
toneum group and 41 in the U-shaped retractor elevation group. None lost to follow-
up
Interventions Laparoscopic surgery using insufation of carbon dioxide gas (technique unclear) versus
a gasless abdominal wall retractor (technique unclear). No co-intervention. Standardised
operative training in both interventions especially for the study. Standardised operative
technique was deployed by all operators
Outcomes Aim: Assessing technical feasibility. Reported primary complications including vascular
and solid organ injury and secondary complications including extraperitoneal insufa-
tion and wound infection
Notes Multi-centre at Kitakyushu, Japan and Fukuoka, Japan.
Risk of bias
bias)
Low risk Forty-two patients were randomly allo-
cated to the pneumoperitoneum (P) group
and 41 to the U-shaped retractor (U) group
by using a system of randomized numbers.

Kitano 1993 (Continued)
made.
bias)
All outcomes
Unclear risk No reference to blinding.
All outcomes
Low risk No exclusions or drop outs stated.
not stated for each outcome. No omission
Other bias Low risk No further bias issues identied.
Lam 2000
Participants Patients over the age of 18 and likely to benet from laparoscopic cholecystectomy. Ex-
clusion criteria was based upon the presence of inammatory conditions and malignancy.
30 in the radially expanding (STEP) trocar group and 31 in the standard trocar group.
Seven lost to follow-up
Interventions Radially expanding (STEP) trocars versus standard trocars for secondary port entry. No
co-intervention
Outcomes Major complications (specic complications not stated). Trocar site bleeding and wound
infection
Notes Single-centre trial.
Risk of bias
bias)
Low risk Truly randomised.
bias)
All outcomes
Low risk Single blinded study (patients only).
Lam 2000 (Continued)
All outcomes
Unclear risk Major complications (specic complica-
tions not stated), authors have been con-
tacted
Selective reporting (reporting bias) Low risk No specic reporting issues identied.
Mettle 2000
Participants Three surgeons at 2 centres enrolled 100 patients undergoing elective laparoscopic gy-
naecological surgical procedures. Exclusion criteria was based upon acute inammatory
conditions. 49 participants in the Radially expanding (STEP) trocar group and 51 in
the Veress needle group. None lost to follow-up
Interventions Radially expanding (STEP) trocars (technique not stated) versus standard trocars (tech-
nique not stated). No co-intervention. Standardised operative training in both inter-
ventions especially for the study. Standardised operative technique was deployed by all
operators
Outcomes Aim: Assessing complications. Reported primary complications including vascular and
visceral injury and secondary complications including failed entry and wound bleeding
Notes Multi-centre at Kiel, Germany and Victoria, Australia.
Risk of bias
bias)
Low risk Patients were randomised into either Step
(S; n = 49) or conventional technique (C;
n = 51) groups according to which kind
of laparoscopic access device was assigned
from the randomisation table.
made.
bias)
All outcomes
Unclear risk No reference to blinding within paper.
All outcomes
Low risk No loss to follow up or exclusions stated.
Mettle 2000 (Continued)
subsets of data. Power calculationnot stated
Other bias Low risk No evidence of further bias identied.
Minervini 2008
Participants Patients admitted for transperitoneal laparoscopic procedures for renal pathology were
included. No exclusion criteria. 27 participants in the open group and 33 to the blade
less group. No loss to follow up stated
Interventions Hasson trocar inserted by standard technique versus a 12mm blade less trocar. No co-
intervention. Standardised surgical technique deployed
Outcomes Mean time to closure; failed entry, gas leak, intra-abdominal injury and port site herni-
ation
Notes Single-centre trial at University of Florence, Italy.
Risk of bias
bias)
Unclear risk Method of randomisation not clearly stated.
Allocation concealment (selection bias) Unclear risk Not stated.
bias)
All outcomes
All outcomes
Unclear risk No exclusions or drop-outs stated.
Selective reporting (reporting bias) Unclear risk Data was presented as number of cases and percentages;
no conversion of data. P values not stated for each out-
come. No omission of outcomes and no subsets of data.
Power calculation not performed
Ostrzenski 1999
Methods Randomisedcontrolledtrial whichwas single-blindedbetweenJanuary 1992andJanuary
1995. Study duration 3 years
Participants Patients were recruited between Jan 1992 and Jan 1995. Elective diagnostic and/or op-
erative laparoscopic cases were included. Exclusion criteria included previous abdominal
surgery, abdominal or pelvic adhesions, severe endometriosis, stulae formation, IBS,
diaphragmatic herniae, cardiopulmonary disease and abdo-pelvic organ enlargement.
Exclusion was not based upon age and BMI. 50 participants in the closed technique
group and 50 in the parallel technique group. None lost to follow-up
Interventions Closed (technique unclear) versus Parallel (Trenedenburg position, incision made at the
lower end of the umbilicus, no abdominal wall elevation and Veress Needle was advanced
through the abdominal wall aiming towards the sacral hallow) technique of Veress needle
insertion. No co-intervention. Standardised operative training in both interventions
especially for the study. Standardised operative techniques was deployed by all operators
Outcomes Aim: Assessing safety and efcacy. Reported primary complications including vascular
and visceral injury and secondary complications including extraperitoneal insufation
Risk of bias
bias)
Unclear risk To prevent bias related to preoperative ex-
pectations, patients were randomized by
sealed envelope in the operating roomafter
the induction of anesthesia.
Allocation concealment (selection bias) Unclear risk To prevent bias related to preoperative ex-
pectations, patients were randomized by
sealed envelope in the operating roomafter
the induction of anesthesia.
bias)
All outcomes
Low risk Single blinded, patients only.
All outcomes
Low risk No exclusions or drop-outs reported.
not stated
Santala 1999
Participants One hundred consecutive women with a BMI of >25 kg/m2 attending clinic for steril-
ization were enrolled into the trial. Exclusion criteria included history of PID, adhesions
obliterating the cul-de-sac, uterine broids and uterine cavity of more than 10 cm. Ex-
clusion criteria was not base upon age, BMI, height and weight. 50 participants in the
trans fundal group and 50 in the infra-umbilical group. None lost to follow-up
Interventions Transfundal insertion versus infra-umbilical insertion of the Veress needle. No co-inter-
vention. Standardised operative training in both interventions especially for the study.
Standardised operative technique was deployed by all operators
Outcomes Aim: Assessing efcacy and safety. Reported secondary complications including uterine
bleeding and also failed entry
Risk of bias
bias)
Low risk For allocation into study groups, we used
sealed envelopes prepared in blocks of 20
Allocation concealment (selection bias) Low risk For allocation into study groups, we used
sealed envelopes prepared in blocks of 20
bias)
All outcomes
Unclear risk Not stated within study.
All outcomes
Low risk No exclusions, drop outs or loss to follow-
up stated.
Selective reporting (reporting bias) Unclear risk Data was presented as number of cases ; no
not stated
Schulze 1999
Methods Randomised controlled trial which not blinded.
Participants 22 patients provided informed consent and entered the study. Exclusion criteria included
extensive tumour growth and rectal surgery. Patients were randomised to either gasless
(n=9) or conventional CO2 (n=8) surgery. 5 lost to follow-up
Interventions Gasless (technique published elsewhere) versus conventional surgery (technique pub-
lished elsewhere). No co-intervention. Standardised operative technique was deployed
by all operators
Outcomes Aim: Assessing cardiopulmonary and systemic changes. Reported any complications
which occurred (Pneumonia, brachial artery embolism, incarcerated inguinal hernias)
Authors reported changes in cardiovascular and respiratory function
Notes Single centre at Copenhagen, Denmark.
Risk of bias
bias)
Allocation concealment (selection bias) Unclear risk Allocation concealment not discussed
within the paper.
bias)
All outcomes
Unclear risk Not blinded.
All outcomes
Unclear risk Reported patients as lost to follow-up be-
cause of conversion to a different tech-
nique, and therefore
an intention-to-treat analysis may have
been of value.Five patients were excluded
because of conversion fromlaparoscopic to
open surgery (2 in the GL group and 3 in
the CO2 group).
subsets of data. Power calculationnot stated
Tansatit 1 2006
Participants Patients referred from the infertility clinic for laparoscopic diagnosis. Exclusion criteria
based upon suspicion of adhesions, prior abdominal surgery, midline vertical scars, his-
tory of peritonitis and large pelvic/abdominal masses. Exclusion was not based upon age
and BMI. 50 in the missile trocar group and 50 in the Veress Needle group. None lost
to follow-up
Interventions Direct trocar (technique not stated) versus Veress Needle (technique not stated). All op-
erators had learnt the technique on cadavers. No co-intervention. Standardised operative
training in both interventions especially for the study. Standardised operative technique
was deployed by all operators
Outcomes Aim: Assessing technical feasibility. Stated no carbon dioxide leakage, abdominal wall
haematoma or serious complications occurred
Notes Single centre at Bangkok, Thailand.
Risk of bias
bias)
Unclear risk Method of randomisation unclear. Allo-
cated by simple randomisation
Allocation concealment (selection bias) Unclear risk Allocated by simple randomisation
bias)
All outcomes
Unclear risk Unclear as not stated in study.
All outcomes
Unclear risk Authors have been written to in order to
clarify if any data was collected on compli-
cations. This will be included within up-
date if a response is received. No exclusions
or drop-outs included
Selective reporting (reporting bias) Low risk Data was presented as number of cases
and means; no conversion of data. P val-
ues stated for each outcome. No omission
Tansatit 2 2006
Methods Randomised controlled trial which was single-blinded. 50 in the missile trocar group
and 50 in the Veress Needle group. None lost to follow-up. Single centre at Bangkok,
Thailand
and BMI
Interventions Direct trocar (technique not stated) versus Veress Needle (technique not stated). All op-
erators had learnt the technique on cadavers. No co-intervention. Standardised operative
training in both interventions especially for the study. Standardised operative technique
was deployed by all operators
Outcomes Aim: Assessing technical feasibility. Only stated the primary complications did not
occur
Notes
Risk of bias
bias)
bias)
All outcomes
All outcomes
or drop outs included
Tansatit 3 2006
Methods Randomised controlled trial which was single-blinded. 50 in the missile trocar group
and 50 in the Veress needle group. None lost to follow-up. Single centre in Bangkok,
Thailand
and BMI
Interventions Direct trocar (technique not stated) versus reusable Pyramidal trocar (technique not
stated). All operators had learnt the technique on cadavers. No co-intervention. Stan-
dardised operative training in both interventions especially for the study. Standardised
operative technique was deployed by all operators
Outcomes Aim: Assessing technical feasibility. Only stated the primary complications did not
occur
Notes
Risk of bias
bias)
bias)
All outcomes
All outcomes
or drop-outs included
Tinelli 2010
Methods Randomised controlled trial fromJanuary 2004 to October 2008. Study duration 4 years
9 months. Investigated direct optical access versus Veress Needle entry
Participants 194 participants undergoing laparoscopy for simple, persistent ovarian cysts in multiple
gynaecological centres. Patients with preceding open abdominal surgery or in presence
of large ovarian cysts (larger than 9 cm diameter or more) and of previous peri-umbil-
ical surgery, were excluded from the study, together with those reporting the following
ultrasound patterns of malignancy. Participants BMI between 20-28. 93 participants in
direct optical access and 101 in Veress Needle entry group. No loss to follow-up
Interventions Standardised operative technique applied.Participants were randomised for either direct
optical access (DOA) or Veress Needle entry and pneumoperitoneum, prior to operative
laparoscopy
10 mm intra-umbilical incision was made and the abdominal wall was lifted upwards
to enable the introduction of optical conical blunt-tipped trocar in abdomen. Secondly,
an optical blade less trocar -called Endopath Trocars (Ethicon, Johnson & Johnson,
Somerville, NJ, USA), with a 08 illuminated laparoscope (Karl Storz, Tuttlingen, Ger-
many) inside, was inserted directly into the abdominal cavity by applying a constant
axial penetration force, under direct visual identication of the abdominal wall layers,
starting from subcutaneous fat tissue to the rectus sheath and the peritoneum, until
nally verifying the intra-abdominal contents
The classical closed method, using the Veress needle (by Karl Storz Endoscopy, Germany)
followed by pneumoperitoneum; a single-use, conical, blind blunt-tipped trocar (by
Ethicon, Johnson & Johnson, Somerville, NJ, USA) insertion was performed
Outcomes Duration of entry, blood loss, vascular injuries, visceral injuries
Notes Multi-centre trial at Vito Fazzi Hospital, Lecce, Italy, Santa Maria Hospital, Bari, Italy,
Harvard Medical School, Boston, MA, USA, LKH Villach, Austria,The New European
Surgical Academy (NESA), Berlin, Germany, University Hospitals Schleswig-Holstein,
Campus Kiel, Germany
Risk of bias
bias)
Unclear risk The study provided, in every suitable gy-
naecological centre, the allocation of all
suitable consecutive patients with ovarian
cysts to either of the two procedures, with
a randomisation ratio of 1:1
Allocation concealment (selection bias) Unclear risk The study provided, in every suitable gy-
naecological centre, the allocation of all
suitable consecutive patients with ovarian
cysts to either of the two procedures, with
a randomisation ratio of 1:1
Tinelli 2010 (Continued)
bias)
All outcomes
Unclear risk Unclear - not stated.
All outcomes
Low risk All outcomes reported. No exclusions
stated.
Selective reporting (reporting bias) Low risk All P values stated. No conversion of data.
No subgroups of data
Tsimoyiannis 2009
Methods Randomised single-blinded trial investigated SILS versus classic laparoscopic cholecys-
tectomy
Participants Participants attending for laparoscopic cholecystectomy. Exclusion criteria included (a)
BMI more than 30 kg/m2, (b) signs of acute cholecystitis or choledocholithiasis or
attacks of acute pancreatitis, (c) ASAgrade more than II, and (d) lack of written informed
consent. 16 exclusions but no loss to follow-up. 20 participants in each group
Interventions Standardised operative technique applied. SILS technique versus classic four port laparo-
scopic cholecystectomy. No co-intervention
Outcomes Abdominal and shoulder pain. Requirement of analgesics and nausea and vomiting
Notes Single-centre trial at General Hospital of Ioannina, Greece.
Risk of bias
bias)
Unclear risk Randomly assigned to two groups using
a closed envelope containing information
regarding placement into group A or B.
Allocation concealment (selection bias) Unclear risk Randomly assigned to two groups using
a closed envelope containing information
regarding placement into group A or B.
bias)
All outcomes
Low risk SIngle blinded - All patients were in-
formed about the intervention technique
Surgeons were informed about the group
of each patient in the operating room. Two
other investigators, blinded to the group of
each patient, independently recorded post-
Tsimoyiannis 2009 (Continued)
operative pain score, need for analgesics,
and incidences of nausea and vomiting.
All outcomes
Low risk No loss to follow-up stated. Sixteen pa-
tients were excluded because of: signs of
acute cholecystitis (9 patients), clinical and
laboratory ndings of choledocholithiasis
(3 patients; preoperative endoscopic retro-
grade cholangiopancreatography (ERCP)
was performed), attacks of acute pancreati-
tis (2 patients), and ASA grade III classi-
cation (2 patients)
Selective reporting (reporting bias) Low risk Data was presented in an appropriate man-
ner and not converted. Pvalues were stated.
None of the stated outcomes were omitted.
Power calculation performed
Venkatesh 2007
Methods Randomised controlled trial investigating the use of cutting versus dilating disposable
trocars in laparoscopic renal surgery
Participants Patients 18 years old undergoing laparoscopic transperitoneal renal procedures were
invited
to participate in the study. No other exclusion criteria stated. 56 participants
Interventions Comparison of 4-trocar types included 2 cutting (single or pyramidal bladed) and 2
dilating trocars (radially or axially dilating) type
Outcomes Meanpainscores at 3 hours, 24hours and 1 week post operatively. All complications, such
as abdominal wall vessel bleeding, intraabdominal vascular or visceral injuries, related
to the trocar deployment were documented. Trocar-related events during the operative
procedure, such as gas leakage, trocar dislodgment, problems in handling the reducer
mechanism and failure of trocar seal integrity, were documented
Notes Multi-centre trial at Washington University School of Medicine, Division of Urology, St.
Louis, Missouri, USA, Indiana University Medical Center, Department of Urology, In-
dianapolis, USA, University School of Medicine, Medical Statistics, St. Louis, Missouri,
USA, UCI Medical Center, Department of Urology, Irvine, California, USA, Columbia
University Medical Center, Department of Urology, New York, USA
Risk of bias
Venkatesh 2007 (Continued)
bias)
Allocation concealment (selection bias) Unclear risk Not stated.
bias)
All outcomes
All outcomes
Unclear risk No exclusions or loss to follow up stated.
Selective reporting (reporting bias) Unclear risk P values not stated for all outcomes. Out-
comes reported with number of trocar in-
sertions as opposed to number of partici-
pants. Complication outcomes not specif-
ically pre dened. Data was not con-
verted. Power calculation performed for
pain scores
Other bias Low risk No other sources identied.
Yim 2001
Methods Randomised controlled trial which was double blinded between September 1997 and
March 1998. Study duration 7 months
Participants Between Sept 1997 and March 1998, women scheduled for laparoscopic surgery for
adnexal masses in a university teaching hospital were recruited. Exclusion criteria not
stated. 34 in the radially expanding (STEP) trocar group and 34 in the standard trocar
group. No patients lost to follow-up
Interventions Radially expanding (STEP) trocars compared to standard trocars for secondary port
entry. Standardised operative technique applied
Outcomes Incisional hernia, trocar site bleeding and trocar site infection
Notes Single-centre trial at Prince of Wales Hospital, The Chinese University of Hong Kong,
SAR, Hong Kong
Risk of bias
bias)
Low risk The allocation of trocars was based on
computer generated random numbers that
were put inside consecutively labelled,
sealed, opaque envelopes. Numbers were
Yim 2001 (Continued)
disclosed at surgery.
Allocation concealment (selection bias) Low risk The allocation of trocars was based on
computer generated random numbers that
were put inside consecutively labelled,
sealed, opaque envelopes. Numbers were
disclosed at surgery.
bias)
All outcomes
Low risk Double blinded, patient and observer. Pa-
tients and assessors were masked to trocar
assignments.
All outcomes
Low risk No exclusions or drop-outs reported.
performed
Zakerah 2010
Methods Randomised controlled trial investigated the use of direct trocar and Veress Needle entry.
Unclear duration of study
Participants One thousand patients scheduled to undergo diagnostic laparoscopy were recruited for
the study. No exclusion criteria stated but demographics examined. 500 participants in
direct trocar group and 500 participants in Veress Needle group. No loss to follow-up
stated
Interventions Standardised operative technique stated. The technique of DT entry started with an
intra-umbilical skinincisionwide enoughtoaccommodate the diameter of a sharptrocar/
canal system. The anterior abdominal wall was adequately elevated by hand, and the
trocar was inserted directly into the abdominal cavity, aiming towards the pelvic hollow.
After removal of the sharp trocar, the laparoscope was inserted to conrm the presence
of omentum or bowel in the visual eld, then pneumoperitoneum was started.
Outcomes Length of procedure, gas usage, failed entry and minor intra-operative complications
Notes Single centre trial at Department of Obstetrics and Gynecology, Womens Health Centre,
Assiut University, Assiut , Egypt
Risk of bias
Zakerah 2010 (Continued)
bias)
Low risk They were randomly assigned to either DT
(group A, n = 500 patients) or VN (group
B, n = 500 patients) entry for pneumoperi-
toneumby a computer-generatedrandomi-
sation table
Allocation concealment (selection bias) Low risk They were randomly assigned to either DT
(group A, n = 500 patients) or VN (group
B, n = 500 patients) entry for pneumoperi-
toneumby a computer-generatedrandomi-
sation table
bias)
All outcomes
All outcomes
Low risk All outcomes reported. No exclusions or
drop outs stated. No loss to follow-up
stated
Selective reporting (reporting bias) Unclear risk P values not stated for demographics. Dif-
ferent statistical analysis used for outcomes.
No power calculation
Characteristics of excluded studies [ordered by study ID]
Study Reason for exclusion
Joshipura 2009 Study evaluated the maintenance of the pneumoperitoneum as opposed to port entry technique
Kim 2009 Study evaluated the differences between operative technique as opposed to port entry
Sandhu 2009 Study evaluated the maintenance of the pneumoperitoneum as opposed to port entry technique
D A T A A N D A N A L Y S E S
Comparison 1. Open-entry technique versus closed-entry technique
Outcome or subgroup title
No. of
studies
No. of
participants
Statistical method Effect size
1 Mortality 2 80 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
1.1 Open entry technique
versus direct trocar entry
1 40 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
versus Veress Needle entry
technique
2 Vascular injury 1 150 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.14 [0.00, 6.82]
technique
3 Visceral (bladder or bowel)
injury
technique
6 Failed entry 1 70 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.12 [0.02, 0.92]
technique
7 Extraperitoneal insufation 2 220 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.36 [0.05, 2.61]
technique
8 Trocar site bleeding 1 150 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.14 [0.00, 6.82]
technique
9 Infection 2 220 Peto Odds Ratio (Peto, Fixed, 95% CI) 1.21 [0.36, 4.04]
technique
10 Omentum injury 1 70 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.14 [0.00, 6.82]
technique
Comparison 2. Direct trocar entry versus Veress Needle entry
No. of
studies
No. of
participants
1 Mortality 2 638 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
injury
4 Gas embolism 2 810 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
5 Solid organ injury 1 598 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.16 [0.01, 2.53]
7 Extraperitoneal insufation 5 2640 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.18 [0.13, 0.26]
9 Infection 1 212 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.15 [0.00, 7.36]
10 Omentum injury 2 1212 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.28 [0.14, 0.55]
Comparison 3. Direct-vision entry versus Veress Needle entry
No. of
studies
No. of
participants
injury
Comparison 4. Direct-vision entry versus open-entry technique
No. of
studies
No. of
participants
Comparison 6. Radially expanding (STEP) trocars versus standard trocars (primary port entry)
No. of
studies
No. of
participants
injury
Comparison 9. Comparisons of sites of entry
No. of
studies
No. of
participants
1 Transfundal versus
infra-umbilical insertion of the
Veress Needle
1 Peto Odds Ratio (Peto, Fixed, 95% CI) Subtotals only
1.6 Failed entry 1 100 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.14 [0.00, 6.82]
1.12 Uterine bleeding 1 100 Peto Odds Ratio (Peto, Fixed, 95% CI) 7.70 [0.78, 75.76]
Comparison 10. Comparisons of other laparoscopic-entry techniques
No. of
studies
No. of
participants
1 Lifting versus not lifting the
abdominal wall before Veress
Needle insertion
1.3 Visceral (bladder or
bowel) injury
1.6 Failed entry 1 150 Peto Odds Ratio (Peto, Fixed, 95% CI) 4.44 [2.16, 9.13]
1.7 Extraperitoneal
insufation
2 Carbon dioxide gas insufation
versus gasless abdominal wall
retractor
2.2 Vascular injury 2 186 Peto Odds Ratio (Peto, Fixed, 95% CI) 7.23 [0.45, 115.64]
2.7 Extraperitoneal
insufation
2.8 Trocar site
bleeding/haematoma
2.9 Trocar site/wound
infection
3 A closed technique versus a
parallel technique of Veress
Needle insertion
3.2 Vascular injury 1 100 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.0 [0.0, 0.0]
bowel) injury
3.7 Extraperitoneal
insufation
5 Cutting trocars versus blunt
trocars
bowel) injury
5.8 Trocar site bleeding 2 195 Peto Odds Ratio (Peto, Fixed, 95% CI) 0.33 [0.09, 1.23]
infection
7 5 mm versus 3 mm secondary
port trocars
8 Radially expanding (STEP)
secondary trocars versus
standard secondary trocars
infection
Analysis 1.1. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 1 Mortality.
Review: Laparoscopic entry techniques
Comparison: 1 Open-entry technique versus closed-entry technique
Outcome: 1 Mortality
Study or subgroup Open Closed
Peto
Odds Ratio
Peto
Odds Ratio
n/N n/N Peto,Fixed,95% CI Peto,Fixed,95% CI
1 Open entry technique versus direct trocar entry
Bemelman 1 2000 0/20 0/20 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 20 20 0.0 [ 0.0, 0.0 ]
Total events: 0 (Open), 0 (Closed)
Heterogeneity: not applicable
Test for overall effect: Z = 0.0 (P < 0.00001)
2 Open entry technique versus Veress Needle entry technique
Bemelman 2 2000 0/20 0/20 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 20 20 0.0 [ 0.0, 0.0 ]
Total (95% CI) 40 40 0.0 [ 0.0, 0.0 ]
Heterogeneity: Chi
2
= 0.0, df = 0 (P<0.00001); I
2
=0.0%
Test for subgroup differences: Chi
2
= 0.0, df = -1 (P = 0.0), I
2
=0.0%
0.01 0.1 1 10 100
Favours open Favours closed
Analysis 1.2. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 2 Vascular
injury.
Outcome: 2 Vascular injury
Peto
Odds Ratio Weight
Peto
Odds Ratio
Cogliandolo 1998 0/75 1/75 100.0 % 0.14 [ 0.00, 6.82 ]
Total (95% CI) 75 75 100.0 % 0.14 [ 0.00, 6.82 ]
Test for overall effect: Z = 1.00 (P = 0.32)
Test for subgroup differences: Not applicable
0.01 0.1 1 10 100
Analysis 1.3. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 3 Visceral
(bladder or bowel) injury.
Outcome: 3 Visceral (bladder or bowel) injury
Peto
Odds Ratio Weight
Peto
Odds Ratio
Cogliandolo 1998 1/75 1/75 100.0 % 1.00 [ 0.06, 16.14 ]
Total (95% CI) 75 75 100.0 % 1.00 [ 0.06, 16.14 ]
0.01 0.1 1 10 100
Analysis 1.6. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 6 Failed entry.
Outcome: 6 Failed entry
Peto
Odds Ratio Weight
Peto
Odds Ratio
Akbar 2008 0/35 4/35 100.0 % 0.12 [ 0.02, 0.92 ]
Total (95% CI) 35 35 100.0 % 0.12 [ 0.02, 0.92 ]
0.01 0.1 1 10 100
Analysis 1.7. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 7
Extraperitoneal insufation.
Outcome: 7 Extraperitoneal insufation
Peto
Odds Ratio Weight
Peto
Odds Ratio
Akbar 2008 1/35 1/35 49.8 % 1.00 [ 0.06, 16.32 ]
Cogliandolo 1998 0/75 2/75 50.2 % 0.13 [ 0.01, 2.15 ]
Total (95% CI) 110 110 100.0 % 0.36 [ 0.05, 2.61 ]
Heterogeneity: Chi
2
= 1.00, df = 1 (P = 0.32); I
2
=0%
0.01 0.1 1 10 100
Analysis 1.8. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 8 Trocar site
bleeding.
Outcome: 8 Trocar site bleeding
Peto
Odds Ratio Weight
Peto
Odds Ratio
Cogliandolo 1998 0/75 1/75 100.0 % 0.14 [ 0.00, 6.82 ]
Total (95% CI) 75 75 100.0 % 0.14 [ 0.00, 6.82 ]
0.01 0.1 1 10 100
Analysis 1.9. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 9 Infection.
Outcome: 9 Infection
Peto
Odds Ratio Weight
Peto
Odds Ratio
Akbar 2008 1/35 2/35 27.6 % 0.50 [ 0.05, 5.00 ]
Cogliandolo 1998 5/75 3/75 72.4 % 1.69 [ 0.41, 6.99 ]
Total (95% CI) 110 110 100.0 % 1.21 [ 0.36, 4.04 ]
Heterogeneity: Chi
2
= 0.77, df = 1 (P = 0.38); I
2
=0.0%
0.01 0.1 1 10 100
Analysis 1.10. Comparison 1 Open-entry technique versus closed-entry technique, Outcome 10 Omentum
injury.
Outcome: 10 Omentum injury
Peto
Odds Ratio Weight
Peto
Odds Ratio
Akbar 2008 0/35 1/35 100.0 % 0.14 [ 0.00, 6.82 ]
Total (95% CI) 35 35 100.0 % 0.14 [ 0.00, 6.82 ]
0.01 0.1 1 10 100
Analysis 2.1. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 1 Mortality.
Comparison: 2 Direct trocar entry versus Veress Needle entry
Outcome: 1 Mortality
Study or subgroup Direct trocar Veress Needle
Peto
Odds Ratio
Peto
Odds Ratio
Agresta 2004 0/275 0/323 0.0 [ 0.0, 0.0 ]
Bemelmen 3 2000 0/20 0/20 0.0 [ 0.0, 0.0 ]
Total (95% CI) 295 343 0.0 [ 0.0, 0.0 ]
Total events: 0 (Direct trocar), 0 (Veress Needle)
Heterogeneity: Chi
2
= 0.0, df = 0 (P<0.00001); I
2
=0.0%
0.01 0.1 1 10 100
Favours direct trocar Favours Veress Needle
Analysis 2.2. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 2 Vascular injury.
Peto
Odds Ratio
Peto
Odds Ratio
Agresta 2004 0/275 0/323 0.0 [ 0.0, 0.0 ]
Total (95% CI) 275 323 0.0 [ 0.0, 0.0 ]
0.01 0.1 1 10 100
Analysis 2.3. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 3 Visceral (bladder or
bowel) injury.
Peto
Odds Ratio
Peto
Odds Ratio
Agresta 2004 0/275 0/323 0.0 [ 0.0, 0.0 ]
Total (95% CI) 275 323 0.0 [ 0.0, 0.0 ]
0.01 0.1 1 10 100
Analysis 2.4. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 4 Gas embolism.
Outcome: 4 Gas embolism
Peto
Odds Ratio
Peto
Odds Ratio
Agresta 2004 0/275 0/323 0.0 [ 0.0, 0.0 ]
Borgatta 1990 0/102 0/110 0.0 [ 0.0, 0.0 ]
Total (95% CI) 377 433 0.0 [ 0.0, 0.0 ]
Heterogeneity: Chi
2
= 0.0, df = 0 (P<0.00001); I
2
=0.0%
0.01 0.1 1 10 100
Analysis 2.5. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 5 Solid organ injury.
Outcome: 5 Solid organ injury
Peto
Odds Ratio Weight
Peto
Odds Ratio
Agresta 2004 0/275 2/323 100.0 % 0.16 [ 0.01, 2.53 ]
Total (95% CI) 275 323 100.0 % 0.16 [ 0.01, 2.53 ]
0.01 0.1 1 10 100
Analysis 2.6. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 6 Failed entry.
Peto
Odds Ratio Weight
Peto
Odds Ratio
Agresta 2004 0/275 4/323 4.0 % 0.16 [ 0.02, 1.12 ]
Borgatta 1990 0/102 2/110 2.0 % 0.14 [ 0.01, 2.33 ]
Byron 1993 2/111 4/141 5.8 % 0.64 [ 0.13, 3.27 ]
Gunec 2005 2/301 13/277 14.6 % 0.20 [ 0.07, 0.57 ]
Zakerah 2010 10/500 70/500 73.7 % 0.20 [ 0.12, 0.31 ]
Total (95% CI) 1289 1351 100.0 % 0.21 [ 0.14, 0.31 ]
Heterogeneity: Chi
2
= 2.05, df = 4 (P = 0.73); I
2
=0.0%
0.01 0.1 1 10 100
Analysis 2.7. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 7 Extraperitoneal
insufation.
Outcome: 7 Extraperitoneal insufation
Peto
Odds Ratio Weight
Peto
Odds Ratio
Agresta 2004 0/275 19/323 16.1 % 0.15 [ 0.06, 0.37 ]
Borgatta 1990 0/102 4/110 3.5 % 0.14 [ 0.02, 1.02 ]
Byron 1993 1/111 7/141 6.8 % 0.27 [ 0.07, 1.10 ]
Gunec 2005 0/301 10/277 8.7 % 0.12 [ 0.03, 0.42 ]
Zakerah 2010 10/500 70/500 65.0 % 0.20 [ 0.12, 0.31 ]
Total (95% CI) 1289 1351 100.0 % 0.18 [ 0.13, 0.26 ]
Heterogeneity: Chi
2
= 1.07, df = 4 (P = 0.90); I
2
=0.0%
0.01 0.1 1 10 100
Analysis 2.9. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 9 Infection.
Outcome: 9 Infection
Peto
Odds Ratio Weight
Peto
Odds Ratio
Borgatta 1990 0/102 1/110 100.0 % 0.15 [ 0.00, 7.36 ]
Total (95% CI) 102 110 100.0 % 0.15 [ 0.00, 7.36 ]
0.01 0.1 1 10 100
Analysis 2.10. Comparison 2 Direct trocar entry versus Veress Needle entry, Outcome 10 Omentum injury.
Outcome: 10 Omentum injury
Peto
Odds Ratio Weight
Peto
Odds Ratio
Borgatta 1990 4/102 7/110 32.7 % 0.61 [ 0.18, 2.05 ]
Zakerah 2010 2/500 20/500 67.3 % 0.19 [ 0.08, 0.44 ]
Total (95% CI) 602 610 100.0 % 0.28 [ 0.14, 0.55 ]
Heterogeneity: Chi
2
= 2.44, df = 1 (P = 0.12); I
2
=59%
0.01 0.1 1 10 100
Analysis 3.3. Comparison 3 Direct-vision entry versus Veress Needle entry, Outcome 3 Visceral (bladder or
bowel) injury.
Comparison: 3 Direct-vision entry versus Veress Needle entry
Study or subgroup Direct vision Veress Needle
Peto
Odds Ratio Weight
Peto
Odds Ratio
Tinelli 2010 0/93 2/101 100.0 % 0.15 [ 0.01, 2.34 ]
Total (95% CI) 93 101 100.0 % 0.15 [ 0.01, 2.34 ]
Total events: 0 (Direct vision), 2 (Veress Needle)
0.01 0.1 1 10 100
Favours direct vision Favours Veress Needle
Analysis 3.8. Comparison 3 Direct-vision entry versus Veress Needle entry, Outcome 8 Trocar site bleeding.
Comparison: 3 Direct-vision entry versus Veress Needle entry
Study or subgroup Direct vision Veress Needle
Peto
Odds Ratio Weight
Peto
Odds Ratio
Tinelli 2010 2/93 4/101 100.0 % 0.55 [ 0.11, 2.78 ]
Total (95% CI) 93 101 100.0 % 0.55 [ 0.11, 2.78 ]
Total events: 2 (Direct vision), 4 (Veress Needle)
0.01 0.1 1 10 100
Favours direct vision Favours Veress Needle
Analysis 4.5. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 5 Solid organ injury.
Comparison: 4 Direct-vision entry versus open-entry technique
Study or subgroup Direct vision Open entry
Peto
Odds Ratio Weight
Peto
Odds Ratio
Minervini 2008 1/33 0/27 100.0 % 6.16 [ 0.12, 316.67 ]
Total (95% CI) 33 27 100.0 % 6.16 [ 0.12, 316.67 ]
Total events: 1 (Direct vision), 0 (Open entry)
0.01 0.1 1 10 100
Favours direct vision Favours open entry
Analysis 4.6. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 6 Failed entry.
Peto
Odds Ratio Weight
Peto
Odds Ratio
Minervini 2008 1/33 2/27 100.0 % 0.40 [ 0.04, 4.09 ]
Total (95% CI) 33 27 100.0 % 0.40 [ 0.04, 4.09 ]
0.01 0.1 1 10 100
Analysis 4.8. Comparison 4 Direct-vision entry versus open-entry technique, Outcome 8 Trocar site
bleeding.
Peto
Odds Ratio Weight
Peto
Odds Ratio
Minervini 2008 1/33 0/27 100.0 % 6.16 [ 0.12, 316.67 ]
Total (95% CI) 33 27 100.0 % 6.16 [ 0.12, 316.67 ]
0.01 0.1 1 10 100
Analysis 6.2. Comparison 6 Radially expanding (STEP) trocars versus standard trocars (primary port
entry), Outcome 2 Vascular injury.
Comparison: 6 Radially expanding (STEP) trocars versus standard trocars (primary port entry)
Study or subgroup Radially expandg Standard
Peto
Odds Ratio Weight
Peto
Odds Ratio
Bhoyrul 2000 0/119 1/125 17.3 % 0.14 [ 0.00, 7.16 ]
Feste 2000 1/45 4/42 82.7 % 0.26 [ 0.04, 1.59 ]
Total (95% CI) 164 167 100.0 % 0.24 [ 0.05, 1.21 ]
Total events: 1 (Radially expandg), 5 (Standard)
Heterogeneity: Chi
2
= 0.08, df = 1 (P = 0.78); I
2
=0.0%
0.01 0.1 1 10 100
Favours radially expandg Favours standard
entry), Outcome 3 Visceral (bladder or bowel) injury.
Peto
Odds Ratio
Peto
Odds Ratio
Bhoyrul 2000 0/119 0/125 0.0 [ 0.0, 0.0 ]
Feste 2000 0/45 1/42 0.13 [ 0.00, 6.37 ]
Total (95% CI) 164 167 0.13 [ 0.00, 6.37 ]
Heterogeneity: Chi
2
= 0.0, df = 0 (P = 1.00); I
2
=0.0%
0.01 0.1 1 10 100
entry), Outcome 5 Solid organ injury.
Peto
Odds Ratio Weight
Peto
Odds Ratio
Bhoyrul 2000 1/119 1/125 100.0 % 1.05 [ 0.07, 16.91 ]
Total (95% CI) 119 125 100.0 % 1.05 [ 0.07, 16.91 ]
0.01 0.1 1 10 100
entry), Outcome 8 Trocar site bleeding.
Peto
Odds Ratio Weight
Peto
Odds Ratio
Bhoyrul 2000 0/119 13/125 39.8 % 0.13 [ 0.04, 0.39 ]
Bisgaard 2007 10/38 14/39 53.9 % 0.64 [ 0.25, 1.68 ]
Mettle 2000 0/49 2/51 6.4 % 0.14 [ 0.01, 2.24 ]
Total (95% CI) 206 215 100.0 % 0.31 [ 0.15, 0.62 ]
Heterogeneity: Chi
2
= 4.96, df = 2 (P = 0.08); I
2
=60%
0.01 0.1 1 10 100
Analysis 9.1. Comparison 9 Comparisons of sites of entry, Outcome 1 Transfundal versus infra-umbilical
insertion of the Veress Needle.
Comparison: 9 Comparisons of sites of entry
Outcome: 1 Transfundal versus infra-umbilical insertion of the Veress Needle
Study or subgroup Transfundal Infra-umbilical
Peto
Odds Ratio Weight
Peto
Odds Ratio
6 Failed entry
Santala 1999 0/50 1/50 100.0 % 0.14 [ 0.00, 6.82 ]
Subtotal (95% CI) 50 50 100.0 % 0.14 [ 0.00, 6.82 ]
Total events: 0 (Transfundal), 1 (Infra-umbilical)
12 Uterine bleeding
Santala 1999 3/50 0/50 100.0 % 7.70 [ 0.78, 75.76 ]
Subtotal (95% CI) 50 50 100.0 % 7.70 [ 0.78, 75.76 ]
Total events: 3 (Transfundal), 0 (Infra-umbilical)
2
= 3.05, df = 1 (P = 0.08), I
2
=67%
0.01 0.1 1 10 100
Favours transfundal Favours infra-umbilical
Analysis 10.1. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 1 Lifting
versus not lifting the abdominal wall before Veress Needle insertion.
Comparison: 10 Comparisons of other laparoscopic-entry techniques
Outcome: 1 Lifting versus not lifting the abdominal wall before Veress Needle insertion
Study or subgroup Lifting Not lifting
Peto
Odds Ratio
Peto
Odds Ratio
3 Visceral (bladder or bowel) injury
Briel 2000 0/75 0/75 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 75 75 0.0 [ 0.0, 0.0 ]
Total events: 0 (Lifting), 0 (Not lifting)
6 Failed entry
Briel 2000 31/75 9/75 4.44 [ 2.16, 9.13 ]
Subtotal (95% CI) 75 75 4.44 [ 2.16, 9.13 ]
7 Extraperitoneal insufation
Briel 2000 6/75 1/75 4.43 [ 0.98, 20.10 ]
Subtotal (95% CI) 75 75 4.43 [ 0.98, 20.10 ]
0.01 0.1 1 10 100
Favours lifting Favours not lifting
Analysis 10.2. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 2 Carbon
dioxide gas insufation versus gasless abdominal wall retractor.
Outcome: 2 Carbon dioxide gas insufation versus gasless abdominal wall retractor
Study or subgroup Carbon dioxide
Gasless
abdo
retractor
Peto
Odds Ratio Weight
Peto
Odds Ratio
2 Vascular injury
Cravello 1999 1/52 0/51 50.0 % 7.25 [ 0.14, 365.36 ]
Kitano 1993 1/42 0/41 50.0 % 7.22 [ 0.14, 363.73 ]
Subtotal (95% CI) 94 92 100.0 % 7.23 [ 0.45, 115.64 ]
Total events: 2 (Carbon dioxide), 0 (Gasless abdo retractor)
Heterogeneity: Chi
2
= 0.00, df = 1 (P = 1.00); I
2
=0.0%
Kitano 1993 3/42 0/41 100.0 % 7.58 [ 0.77, 74.97 ]
Subtotal (95% CI) 42 41 100.0 % 7.58 [ 0.77, 74.97 ]
8 Trocar site bleeding/haematoma
Cravello 1999 0/52 1/51 100.0 % 0.13 [ 0.00, 6.69 ]
Subtotal (95% CI) 52 51 100.0 % 0.13 [ 0.00, 6.69 ]
9 Trocar site/wound infection
Kitano 1993 1/42 1/41 100.0 % 0.98 [ 0.06, 15.87 ]
Subtotal (95% CI) 42 41 100.0 % 0.98 [ 0.06, 15.87 ]
2
= 4.05, df = 3 (P = 0.26), I
2
=26%
0.01 0.1 1 10 100
Favours CO2 Favours gasless retractor
Analysis 10.3. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 3 A closed
technique versus a parallel technique of Veress Needle insertion.
Outcome: 3 A closed technique versus a parallel technique of Veress Needle insertion
Study or subgroup Closed technique
Parallel
Veress
Needle
Peto
Odds Ratio
Peto
Odds Ratio
2 Vascular injury
Ostrzenski 1999 0/50 0/50 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 50 50 0.0 [ 0.0, 0.0 ]
Total events: 0 (Closed technique), 0 (Parallel Veress Needle)
Ostrzenski 1999 0/50 0/50 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 50 50 0.0 [ 0.0, 0.0 ]
Ostrzenski 1999 0/50 0/50 0.0 [ 0.0, 0.0 ]
Subtotal (95% CI) 50 50 0.0 [ 0.0, 0.0 ]
2
= 0.0, df = -1 (P = 0.0), I
2
=0.0%
0.01 0.1 1 10 100
Favours closed Favours parallel V Needle
Analysis 10.5. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 5 Cutting
trocars versus blunt trocars.
Outcome: 5 Cutting trocars versus blunt trocars
Study or subgroup Cutting Blunt
Peto
Odds Ratio Weight
Peto
Odds Ratio
Venkatesh 2007 1/81 0/84 100.0 % 7.67 [ 0.15, 386.69 ]
Subtotal (95% CI) 81 84 100.0 % 7.67 [ 0.15, 386.69 ]
Total events: 1 (Cutting), 0 (Blunt)
8 Trocar site bleeding
Hamade 2007 0/15 2/15 22.3 % 0.13 [ 0.01, 2.12 ]
Venkatesh 2007 2/81 5/84 77.7 % 0.43 [ 0.09, 1.93 ]
Subtotal (95% CI) 96 99 100.0 % 0.33 [ 0.09, 1.23 ]
Heterogeneity: Chi
2
= 0.56, df = 1 (P = 0.46); I
2
=0.0%
Venkatesh 2007 1/81 0/84 100.0 % 7.67 [ 0.15, 386.69 ]
Subtotal (95% CI) 81 84 100.0 % 7.67 [ 0.15, 386.69 ]
2
= 4.06, df = 2 (P = 0.13), I
2
=51%
0.01 0.1 1 10 100
Favours cutting Favours blunt
Analysis 10.7. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 7 5 mm
versus 3 mm secondary port trocars.
Outcome: 7 5 mm versus 3 mm secondary port trocars
Study or subgroup 5 mm 3 mm
Peto
Odds Ratio Weight
Peto
Odds Ratio
Ghezzi 2005 0/50 2/52 100.0 % 0.14 [ 0.01, 2.24 ]
Subtotal (95% CI) 50 52 100.0 % 0.14 [ 0.01, 2.24 ]
Total events: 0 (5 mm), 2 (3 mm)
0.01 0.1 1 10 100
Favours 5 mm Favours 3 mm
Analysis 10.8. Comparison 10 Comparisons of other laparoscopic-entry techniques, Outcome 8 Radially
expanding (STEP) secondary trocars versus standard secondary trocars.
Outcome: 8 Radially expanding (STEP) secondary trocars versus standard secondary trocars
Study or subgroup Experimental Control
Peto
Odds Ratio Weight
Peto
Odds Ratio
Yim 2001 0/34 4/34 100.0 % 0.12 [ 0.02, 0.92 ]
Subtotal (95% CI) 34 34 100.0 % 0.12 [ 0.02, 0.92 ]
Total events: 0 (Experimental), 4 (Control)
Lam 2000 0/30 2/31 100.0 % 0.14 [ 0.01, 2.21 ]
Subtotal (95% CI) 30 31 100.0 % 0.14 [ 0.01, 2.21 ]
Total events: 0 (Experimental), 2 (Control)
2
= 0.00, df = 1 (P = 0.96), I
2
=0.0%
0.01 0.1 1 10 100
Favours expanding 2ndary Favours standard 2ndary
A P P E N D I C E S
Appendix 1. MDSG search strategy
Keywords CONTAINS laparoscopicorlaparoscopic techniquesorlaparoscopy or Keywords CONTAINS laparo-
scopicorlaparoscopic techniquesorlaparoscopy
AND
Keywords CONTAINS entry site or trocar or trocar - dilating-tip ortrocar - non-shielded-bladder ortrocar ports or Veress
needle or pneumoperitoneum or direct trocar insertion or gas orgasless or carbon dioxide or Title CONTAINS entry
site or trocar or trocar - dilating-tip ortrocar - non-shielded-bladder ortrocar ports or Veress needle or pneumoperitoneum
or direct trocar insertion or gas orgasless or carbon dioxide
Appendix 2. EMBASE search strategy
Database: EMBASE <1980 to 2011 Week 04>
1 entry technique$.tw. (106)
2 (Veress or veress-needle$).tw. (422)
3 trocar$.tw. (4668)
4 open entr$.tw. (36)
5 closed entr$.tw. (16)
6 pneumoperiton$.tw. (5382)
7 exp body position/ or exp body posture/ (72965)
8 supine position$.tw. (8104)
9 lithotomy.tw. (953)
10 (patient$ adj2 position$).tw. (5463)
11 French position$.tw. (18)
12 American position$.tw. (10)
13 (side adj2 position$).tw. (745)
14 (side adj approach$).tw. (69)
15 direct-trocar$.tw. (54)
16 gas.tw. (170652)
17 disposable instrument$.tw. (181)
18 reusable instrument$.tw. (110)
19 trendelenburg.tw. (1045)
20 radially expanding.tw. (62)
21 direct vision.tw. (2000)
22 (trans fundal or transfundal).tw. (35)
23 carbon dioxide.tw. (30404)
24 gasless.tw. (454)
25 infra umbilical.tw. (55)
26 infraumbilical.tw. (278)
27 TrocDoc.tw. (1)
28 lift$.tw. (14844)
29 blind.tw. (143669)
30 open approach.tw. (1405)
31 missile.tw. (1292)
32 pyramidal.tw. (24577)
33 u shaped retractor$.tw. (2)
34 intra abdominal pressure.tw. (1704)
35 or/1-34 (468022)
36 exp laparoscopic surgery/ or exp laparoscopy/ (72261)
37 laparoscop$.tw. (76230)
38 (pelvi$ adj2 endoscop$).tw. (57)
39 peritoneoscop$.tw. (663)
40 videolaparoscop$.tw. (380)
41 laparoendoscop$.tw. (408)
42 or/36-41 (92395)
43 35 and 42 (9875)
44 Clinical Trial/ (825855)
45 Randomized Controlled Trial/ (288242)
46 exp randomization/ (53305)
47 Single Blind Procedure/ (13794)
48 Double Blind Procedure/ (101146)
49 Crossover Procedure/ (30017)
50 Placebo/ (174020)
51 Randomi?ed controlled trial$.tw. (59135)
52 Rct.tw. (6369)
53 random allocation.tw. (1015)
54 randomly allocated.tw. (15103)
55 allocated randomly.tw. (1690)
56 (allocated adj2 random).tw. (682)
57 Single blind$.tw. (10686)
58 Double blind$.tw. (115688)
59 ((treble or triple) adj blind$).tw. (231)
60 placebo$.tw. (154565)
61 prospective study/ (162435)
62 or/44-61 (1114901)
63 case study/ (11000)
64 case report.tw. (196337)
65 abstract report/ or letter/ (767787)
66 or/63-65 (971447)
67 62 not 66 (1082594)
68 43 and 67 (1900)
69 (2010$ or 2011$).em. (1235539)
70 68 and 69 (227)
Appendix 3. Medline search strategy
Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)
<1946 to Present>
1 exp laparoscopy/ or exp hand-assisted laparoscopy/ (53665)
7 or/1-6 (70746)
10 trocar$.tw. (3675)
14 exp Pneumoperitoneum, Articial/ (3367)
15 exp posture/ or exp supine position/ (53993)
24 gas.tw. (147779)
32 gasless.tw. (387)
35 TrocDoc.tw. (1)
36 lift$.tw. (13027)
37 blind.tw. (121094)
39 missile.tw. (1248)
43 or/8-42 (397642)
44 7 and 43 (8458)
45 randomized controlled trial.pt. (295829)
46 controlled clinical trial.pt. (80721)
47 randomized.ab. (212749)
48 placebo.tw. (127325)
49 clinical trials as topic.sh. (150348)
50 randomly.ab. (157322)
51 trial.ti. (91133)
52 (crossover or cross-over or cross over).tw. (48814)
53 or/45-52 (723189)
54 exp animals/ not humans.sh. (3482569)
55 53 not 54 (668350)
56 44 and 55 (1223)
57 (2007$ or 2008$ or 2009$ or 2010$ or 2011$).ed. (3346666)
58 56 and 57 (343)
Appendix 4. CENTRAL search strategy
Database: EBM Reviews - Cochrane Central Register of Controlled Trials <4th Quarter 2010>
1 exp laparoscopy/ or exp hand-assisted laparoscopy/ (2745)
7 or/1-6 (4468)
10 trocar$.tw. (164)
14 exp Pneumoperitoneum, Articial/ (185)
15 exp posture/ or exp supine position/ (2786)
24 gas.tw. (5201)
32 gasless.tw. (40)
35 TrocDoc.tw. (1)
36 lift$.tw. (751)
37 blind.tw. (113983)
39 missile.tw. (11)
43 or/8-42 (123740)
44 7 and 43 (1166)
45 limit 44 to yr=2007 -Current (247)
Appendix 5. PsycINFO search strategy
Database: PsycINFO <1806 to January Week 4 2011>
8 trocar$.tw. (3)
12 exp Posture/ (3109)
21 gasless.tw. (0)
22 or/1-5 (185)
23 or/6-21 (4713)
24 22 and 23 (5)
W H A T S N E W
Last assessed as up-to-date: 1 April 2011.
Date Event Description
17 August 2011 New citation required and conclusions have changed Failed entry now considered a major complication. Impli-
cations of failed entry considered e.g. laparotomy, aban-
doned surgery etc. Protocol changed accordingly
Three new comparisons were included in this update; Di-
rect vision versus open entry technique, 5 mm versus 3
mm secondary port trocars, STEP secondary trocars ver-
sus standard trocars
Eleven new trials were included in this update: Akbar
2008, Bisgaard 2007, Feste 2000, Ghezzi 2005, Hamade
2007, Minervini 2008, Tinelli 2010, Tsimoyiannis 2009,
Venkatesh 2007, Yim 2001, Zakerah 2010
Analysis demonstrated new conclusions.
Authorship updated - Helena OFlynn added to author-
ship.
H I S T O R Y
Protocol rst published: Issue 3, 2007
Review rst published: Issue 2, 2008
Date Event Description
11 November 2008 Amended Converted to new review format.
27 January 2008 New citation required and conclusions have changed Substantive amendment
C O N T R I B U T I O N S O F A U T H O R S
Gaity Ahmad (GA)
Main review author, designed the review, screened the search results, organised the retrieval of the RCTs, screened them against the
inclusion criterion, extracted the data from the RCTs, wrote to the authors when required, managed the data, interpreted the results
and supervised JD and HOF throughout the process.
James Duffy (JD)
Co-review author, organised the retrieval of the RCTs in the original review, screened them against the inclusion criteria, extracted the
data from RCTs, wrote to authors when required, managed the data and helped interpret the results.
Helena OFlynn (HOF)
Co-review author, organised the retrieval of the RCTs in the updated review, screened them against the inclusion criteria, extracted the
data from RCTs, wrote to authors when required, managed the data and helped interpret the results.
Kevin Philipps (KP)
Helped design the review and helped draft the discussion and conclusions.
Andrew Watson (AW)
Helped design the review, supervised all the steps undertaken for the review, and settled the differences of opinion between GA, JD
and HOF regarding inclusion of studies. Supervised and helped draft the discussion and conclusion.
D E C L A R A T I O N S O F I N T E R E S T
None known
S O U R C E S O F S U P P O R T
Internal sources
Not specied by review author, Not specied.
External sources
No sources of support supplied
D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W
Studies reviewing secondary port entry are included in the 2011 update of the review.
I N D E X T E R M S
Medical Subject Headings (MeSH)
Gynecologic Surgical Procedures [
adverse effects; methods]; Intraoperative Complications [prevention & control]; Laparoscopy

[
adverse effects; methods]; Randomized Controlled Trials as Topic

MeSH check words
Female; Humans

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Laparoscopic entry techniques (Review)

Ahmad G, OFlynn H, Duffy JMN, Phillips K, Watson A

Agresta F, DeSimone P, Ciardo LF, Bedin N. Direct

Bemelman WA, Dunker MS, Busch ORC, Den Boer KT,

Indicates the major publication for the study

58 Laparoscopic entry techniques (Review)

adverse effects; methods]; Intraoperative Complications [prevention & control]; Laparoscopy

adverse effects; methods]; Randomized Controlled Trials as Topic

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