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Original Article

Arch Clin Exp Surg 2016;X:X-X

Archives of Clinical

doi:10.5455/aces.20160515015524

Experimental Surgery

Increased of Langerhans Cells in Smokeless


Tobacco-Associated
Oral Mucosal Lesions
Open hemorrhoidectomy versus stapler hemorrhoidopexy:
A prospective study

Mumtaz Din Wani, Shabir Ahmad Mir, Saleem Javaid, Yawar Watali

rica Dorigatti de vila1, Rafael Scaf de Molon2, Melaine de Almeida Lawall1, Renata Bianco
Consolaro1, Alberto Consolaro1
ABSTRACT
Background: Stapled hemorrhoidectomy, though significantly less painful, is still in its evolutionary stages, especially in
the developing world. The present study was undertaken to ascertain the efficacy, safety and advantages, if any, of the
stapled hemorrhoidopexy.
Material and Methods: This prospective study comprised of patients admitted for elective surgery of hemorrhoids over
a Abstract
period of 18 months during the period of January 2014 to June 2015 in various surgical wards of SMHS (Shri Maharaja
Hari Singh) Hospital, Srinagar. The patients were randomized into two groups. One group underwent conventional open
hemorrhoidectomy
the other
group,
stapled
Objective: Toand
evaluate
the
changes
inhemorrhoidopexy.
the number of Langerhans Cells (LC) observed in the epithelium of
Results: In our study, the mean operating time for stapled hemorrhoidopexy was 35.227.23 minutes with an average
smokeless tobacco (SLT-induced) lesions.
of 20-50 minutes, while with open hemorrhoidectomy, the mean operating time was 45.6711.94 minutes (p<0.001). The
Methods:
Microscopic
biopsies
carried out inwere
the 1.780.77;
buccal mucosa
of twenty
patients,
mean
VAS scores
at 6, 12 andsections
24 hoursfrom
with stapled
hemorrhoidopexy
1.820.61
and 1.420.62,
re- who were
spectively,
with
hemorrhoidectomy,
the mean
VAS
scores at
12 and
24 hours
were
2.890.86;
2.130.82
chronic and
users
ofopen
smokeless
tobacco (SLT),
were
utilized.
For6, the
control
group,
twenty
non-SLT
users of SLT
and 1.890.80, respectively. The mean hospital stay for patients with stapled hemorrhoidopexy was 1.960.55 days in
with normal
were
selected.
Thehospital
sections
studied with
coloringTheand
were
immunostained
comparison
to themucosa
open group
where
the mean
staywere
was 3.510.72
days routine
(P-value<0.001).
mean
amount
of
blood
loss during
stapled
hemorrhoidectomy
was data
statistically
than in open
surgery;by
thethe
mean
hospitals stay
patients
for S-100,
CD1a,
Ki-67
and p63. These
were less
statistically
analyzed
Student
t-testin to
investigate the
with stapled hemorrhoidopexy was 1.960.55 days versus the open group, where the mean hospital stay was 3.510.72
differences in the expression of immune markers in normal mucosa and in SLT-induced leukoplakia lesions.
days (p <0.001).
Conclusion:
The usewas
of a acircular
stapler difference
in the treatment
of hemorrhoids
is safe, effective,
causes minimal
painnormal
and is mucosa
Results: There
significant
in the
immunolabeling
of all markers
between
associated with fewer complications than conventional hemorrhoidectomy.

and SLT-induced lesions (p<0.001). The leukoplakia lesions in chronic SLT users demonstrated a significant
increase in the number of Langerhans cells and in the absence of epithelial dysplasia.
Conclusion: The increase in the number of these cells represents the initial stage of leukoplakia.
Introduction
method of ascertainment and the definition of hemKey words: Smokeless tobacco, leukoplakic lesions, cancer,
langerhans cells, chewing tobacco.

Key words: Hemorrhoids, stapled, hemorrhoidopexy

From his detailed anatomic study, Thomson[1] orrhoids [2]. Grade III and IV hemorrhoids are betfound that sagging of the anal cushions is the correct ter managed by surgical correction compared to other
etiologic
theory behind hemorrhoids. Not surpris- proposed
conservative
like rubber-band
contact
with procedures,
the oral mucosa
and creates a
Introduction
ingly, the reported prevalence rates of hemorrhoids ligation, sclerotherapy, and cryotherapy [3]. Generally,
more alkaline environment, its products may
Among
users,
there is aonfalse
have varied
widely,tobacco
from 1% to
86%, depending
the be-it involves the resection of hemorrhoidal cushions with

lief that SLT is safe because it is not burned,


which leads many people to quit cigarettes
and start using SLT [1]. However, SLT con-

even be more aggressive to tissue [5]. The


percentage of SLT users is lower compared
to cigarette users; however, usage is increasing
among young individuals and it is therefore a

Author affiliations : Department of Surgery, Government Medical College, Srinagar, India


Correspondence
: Shabir Ahmad Mir, MS, Department of Surgery, Government Medical College, Srinagar, India. e-mail: drshabirmir@gmail.com
Received / Accepted : February 26, 2016 / April 30, 2016

Wani MD et al.

(Fergusons technique) or without (Milligan-Morgan


procedure) suturing the resulting defect.
Lately, there has been a substantial focus on the
use of surgical staplers for the removal of hemorrhoids.
Advocates of this new approach affirm that it is better
than standard closed hemorrhoidectomy in terms of
less postoperative discomfort and faster wound healing. In 1998, Longo [4] provided an initial description
for the correction of prolapsed hemorrhoids by applying a circular stapling device. The important concept
underlying this technique involved drawing up the
enlarged sliding hemorrhoidal tissue, reducing the redundant mucosa, and interfering with the branches of
the superior hemorrhoidal artery without breaching
the integrity of the perianal skin. Patients, therefore,
eliminate the painful skin wound. Hemorrhoidal prolapse is corrected by relocating the pile masses into the
anal canal and by decreasing the venous engorgement
with division of the feeding arteries and redundant mucosa. Through this method, resultant stapled mucosa
anastomosis is formed in the rectum, approximately
30 milimeters proximal to the dentate line where sensitive receptors are sparse. Besides, any anatomization
or wound in the area of the anal mucosa and anoderm
is avoided. It should hypothetically lead to a low incidence of postoperative discomfort and rapid healing.
An internationally acting party experienced in carrying
out the hemorrhoid operation using a circular stapler
assembled in Missillac, France, in July 2001. The expert panel came up with the term stapled hemorrhoidopexy [5].
Background
Stapled hemorrhoidectomy is a significantly less
painful alternative for hemorrhoidectomy. Stapled
hemorrhoidectomy is still in its evolutionary stages, especially in the developing world. Kashmir is not an exception to the issue of hemorrhoids. In this context, the
present study was carried out in a tertiary care hospital
of the Kashmir valley to ascertain the efficacy, safety
and advantage, if any, of the stapled hemorrhoidopexy
in the management of hemorrhoids versus the conventional open technique.
Materials and Methods
This prospective study comprised of patients admitted for elective surgery of hemorrhoids over a peArchives of Clinical and Experimental Surgery

riod of 18 months during the period between January


2014 to June 2015 in various surgical wards of SMHS
(Shri Maharaja Hari Singh) Hospital, Srinagar. The patients were put forth for hemorrhoidectomy after proper clinical evaluation. The patients were initially evaluated in the OPD (outpatient department) and then
admitted for surgery. Upon admission, a detailed history
was taken from each patient, including the presenting
complaints, duration of those complaints, past history,
especially with reference to previous surgery, and any
other associated conditions, such as chronic ailment
and any drug intake. General physical examination was
performed with particular consideration to build, height
and weight followed by systemic examination and a thorough abdominal and rectal examination in each patient.
Rectal examination included digital examination rectal
(DRE), proctoscopy and sigmoidoscopy.
Each patient and their attendants were fully informed of the nature of the procedure in the language
which they understood and written consent was obtained from the patient before surgery. Patients were
informed about the possible complications of the procedures.
The patient characteristics included in the study
were as follows:
Age > 15 years.
Grade 2 or higher hemorrhoids.
Stapled Hemorrhoidopexy
The preparation of the patient was same as for a
conventional hemorrhoidectomy. The procedure was
performed under general or regional anesthesia and the
patient was positioned either in the prone jack-knife
or in the lithotomy position. The equipment, which is
available from a kit, consists of a 33mm stapling gun
with a non-detachable/detachable anvil, a purse-string
speculum, a transparent anal dilator with an operator,
and a purse-string suture threader or crochet hook
(Figure 1). The anal dilator was inserted into the anal
canal and secured in place with heavy sutures to the
perianal skin. The purse-string speculum was then inserted into the anal dilator. By rotating the speculum,
a purse-string of 20 Prolene was placed in the rectum
45 cm above the dentate line in the rectal ampulla,
removing only the mucosalsubmucosal layer. The
stapler with the anvil fully extended was then inserted
Year 2016 | Volume X | Issue X | X-X

Hemorrhoidectomy versus stapler hemorrhoidopexy

Figure 3. Instruments for stapler hemorrhoidopexy.

Figure 1. Instruments used for stapled hemorrhoidopexy. (A) Pursestring suture anoscope; (B) circular anal dilator; (C) suture threader
(crochet hook); (D) 33mm hemorrhoidal circular stapler.
Grade 1

Grade 2

Figure 4A. Pre-op Grade 3 haemorrhoids.

Grade 3

Grade 4

Figure 4B. Complete doughnet after surgery.

Figure 2. Grades of hemorrhoids.

and positioned proximal to the purse string, which was


then tied over the shaft of the anvil. The purse-string
suture tails were retrieved through the ports in the stapler gun using the crochet hook. With moderate traction on the purse string, the prolapsed mucosa and submucosa were drawn into the casing of the stapler and
the stapler tightened and fired. Compression on the
gun was maintained for about 2030 seconds for hemostasis before the stapler was opened and removed.
www.acesjournal.org

Figure 5. Post-op picture of same patient.

Archives of Clinical and Experimental Surgery

Wani MD et al.

Figures 6-8. (6) Pre-op Grade 3 hemorrhoids. (7) Excised hemorroidal masses. (8) Post-excisional hemorrhoidectomy.

Active bleeding points, if present, were stick tied with


an absorbable suture.
Aims
The present study was a prospective randomized
hospital-based study including patients with Grade 2
or higher hemorrhoids. The patients were divided randomly into two groups. One group of patients underwent conventional open hemorrhoidectomy and the
other group, stapled hemorrhoidopexy. The two groups
were compared in terms of the following parameters:
1. Operative time.
2. Bleeding.
3. Postoperative pain assessed by VAS (visual analogue scale) scoring and analgesic requirements.
4. Postoperative complications.
Postoperative bleeding.
Urinary retention
Fever/sepsis.
infection.
5. Hospital stay.
Exclusion Criteria
The following patients were excluded from our study:
1. Patients with uncorrected coagulopathy.
2. Patients with Grade 1 hemorrhoids/
Results and Observations
Age Distribution
In our study, patients fell within the age range of
21-60 years (Table 1). Most patients in the stapled
group were in the age group of 41- 50 years, while in
the open group, they were in the 21-30 years range. The
mean age in the stapled group was 39.699.49 while
in the open group, the mean age was 39.0211.03.(Pvalue=0.759)
Archives of Clinical and Experimental Surgery

Table 1. Age distribution.


Stapled
Age
(in years)

Open

No. of
patients

% age

No. of
patients

% age

21-30

11

24.4

14

31.1

31-40

14

31.1

11

24.4

41-50

15

33.3

13

28.9

51-60

11.1

11.1

>60

0.0

4.4

Total

45

100

45

100

MeanSD

39.699.49

39.0211.03

SD = Standard Deviation; P-value = 0.759

Table 2. Sex distribution.


Stapled

Open

No. of
patients

% age

No. of
patients

% age

Male

24

53.3

33

73.3

Female

21

46.7

12

26.7

Total

45

100

45

100

Gender

P-value = 0.049

Table 3. Duration of surgery.


Stapled
Duration of
surgery
(in minutes)

Open

No. of
patients

% age

No. of
patients

% age

20-30

17

37.8

8.9

31-40

22

48.9

13

28.9

41-50

11.1

16

35.6

>50

2.2

12

26.7

TOTAL

45

100

45

100

MeanSD

35.227.23

45.6711.94

P-value < 0.001

Year 2016 | Volume X | Issue X | X-X

Sex Distribution
In the work presented here, 24 patients (53.3%)
were male and 21 patients (46.7%) were females within the stapled group, while 33 patients (73.3%) were
males and 12 (26.7%) were females in the open group
(Table 2). The difference was statistically insignificant
(P-value = 0.049).
Duration of Surgery
In this study, the mean operating time for the stapled hemorrhoidopexy was 35.227.23 minutes with
average of 20-50 minutes, while in the open hemorrhoidectomy group, the mean operating time was
45.6711.94 minutes (Table 3). The difference was statistically significant with a p-value of < 0.001.
Post Operative Pain
In our study, the mean VAS score at 6, 12 and 24
hours in the stapled hemorrhoidopexy was 1.780.77,
1.820.61 and 1.420.62, respectively, and in the open
hemorrohidectomy group, the mean VAS score at 6, 12
and 24 hours was 2.890.86, 2.130.82 and 1.890.80,
respectively (Table 4). The difference was statistically
significant.
Duration of Hospital Stay
In the present study, the mean hospital stay for
patients with stapled hemrrhoidopexy was 1.960.55
days versus the open group where the mean hospital
stay was 3.510.72 days. The difference was statistically
significant with a P-value < 0.001.
Intra-Operative Bleeding
In this study, we found that the incidence of intraoperative bleeding was more in the stapled group
compared to the conventional open group, but this difference was not statistically significant as described in
Table 6.
However, at the same time, an important observation made was that the mean amount of blood loss during stapled hemorrhoidectomy was less than in open
surgery bearing a statistically significant difference as
depicted in Table 7 below.
Postoperative Complications
In this study, we found urinary retention to be the
most common complication seen in 31.1% and 15.6%
of open and stapled patients, respectively; the difference was, however, statistically insignificant. Bleeding
occurred in 20% and 11.1% of patients in open and stawww.acesjournal.org

Hemorrhoidectomy versus stapler hemorrhoidopexy

Table 4. Post operative pain.


Pain Score (VAS)

Stapled

Open

P-value

6 hours

1.780.77

2.890.86

<0.001

12 hours

1.820.61

2.130.82

0.047

24 hours

1.420.62

1.890.80

0.003

Table 5. Duration of hospital stay.


Stapled
Duration of
hospital stay
(in days)

Open

No. of
patients

% age

No. of
patients

Up to 2

36

80

2.2

2-4

20

35

77.8

% age

>4

20

TOTAL

45

100

45

100

MeanSD

1.960.055

3.510.72

Table 6. Incidence of intra-operative bleeding.


Type of
Surgery

No. of Patients [% age] with


intraoperative bleeding

P-value

Stapled

9 [20%]

0.245

Conventional

5 [11%]

0.245

Table 7. Amount of blood loss.


Operative blood loss [in gms]
of individual patients
Range
Average SD

Stapled

Open

P-value

6-22

15-70

0.021

134.24

4619.96

0.021

Table 8. Postoperative complications.


Stapled

Open

No. of
patients

%
age

No. of
patients

% age

P-value

Retention

15.6

14

31.1

0.081

Bleeding

11.1

20.0

0.245

Infection

Complications

pled groups, respectively, though the difference statistically was insignificant. No postoperative infection was
noted in any of the patients in any of the groups in our
study (Table 8).
Discussion
Hemorrhoidectomy is the accepted method for the
treatment of large symptomatic piles. Conventional
hemorrhoidectomies are effective operations that have
Archives of Clinical and Experimental Surgery

Wani MD et al.

withstood the test of time; however, the problem of


postoperative pain has never been satisfactorily addressed. The postoperative pain related to excisional
hemorrhoidectomy is well known. Patients will frequently avoid definitive treatment of their disease for
many years so as to avoid this very problem. Also, the
high postoperative morbidity and long recovery time
has prompted the need for an alternative procedure.
Several techniques, including diathermy hemorrhoidectomy, dilatation with banding and cryohemorrhoidectomy, have been attempted. Stapled hemorrhoidopexy offers a significantly less painful alternative that
provides patients definitive treatment for their disease
in a single setting.
Stapled hemrrhoidopexy was introduced in 1995
by Longo; a novel technique in dealing with the management of hemorrhoidal disease, it has emerged as an
alternative to open hemorrhoidectomy, long considered the gold standard. It corrects the mucosal prolapse, with simultaneous disruption of blood supply to
hemorrhoidal tissue.
The technique has been standardized and the indications, contraindications, and operative technique
have all been defined. Several randomized trials have
shown the efficacy and safety of procedure. There has
been concern and reluctance in accepting stapled hemorrhoidopexy, as several serious complications have
been reported. These include persistent postoperative
pain, fecal urgency, rectovaginal fistula, rectal obstruction, perforation peritonitis and pelvic sepsis. These
have all been seen by most investigators during the
early part of the procedures learning curve.
Various controlled studies have indicated that stapled hemrrhoidopexy is associated with minimal postoperative pain and early recovery. Right from the earliest research, there has been a high patient satisfaction
rate. However, most of these studies were conducted
in highly specialized centers, and the present study was
designed to compare the short-term results of stapled
hemrrhoidopexy with the MilliganMorgan hemorrhoidectomy. Our aim was to ascertain if the stapled
hemorrhoidopexy performs similarly as is reported in
the literature when the procedure was conducted at independent centers.
90 patients that underwent surgery for hemorArchives of Clinical and Experimental Surgery

rhoids at SMHS Hospital, Srinagar, fulfilled the criteria


and were included in this study. Forty-five (45) underwent the Longo technique of stapled hemorrhoidopexy
and forty-five (45) had the Milligan Morgan technique
of open hemorrhoidectomy.
In our study, the patients were in the age range of
21-60 years. Most of the patients in the stapled group
were in the age group of 41- 50 years, while in the open
group, the majority were in the range of 21-30 years. The
mean age in the stapled group was 39.699.49 while in
the open group, the mean age was 39.0211.03. (Pvalue=0.759). Pergel [6] found that the mean age was
3811.9 (range: 23-76) years. In our study, 24 patients
(53.3%) were male and 21 patients (46.7%) were females in the stapled group, while 33 patients (73.3%)
were males and 12 (26.7%) were females in the open
group. The difference was statistically insignificant.
The duration of surgery (minutes) was compared between the two groups. In the stapled group, 37.8%
underwent surgery within 20-30 min. The mean duration of surgery was 35 min, ranging from 25-55 min.
In the open group, the mean duration of surgery was
46 min, ranging from 25-55 min. Duration of surgery
was significantly low in the stapled group with t=5.018;
p<0.001**. This is similar that observed in other studies. However, the duration was 5-10 minutes different
than observed by others (Khalil KH, 2000; Bikhchandani J, 2005) [7,8]. Tjandra JJ (2007) [9] published
a systemic review on stapled hemorrhoidopexy of all
randomized, controlled trials until August 2006. Stapled hemorrhoidopexy was highly associated with less
operating time (weighted mean difference being 11.35
minutes; p=0.006). In our study, the mean difference
was comparable (11 min). Stolfi et al. (2008) [10], in
a study involving one hundred and seventy-one (171)
patients comparing the stapler hemorrhoidopexy and
Milligan-Morgan technique, found mean surgical time
was 28 min. Hetzer et al (2002) [11] also observed a
mean of 30 min. Dilatation of the anal sphincter before
stapler introduction was routinely performed. The authors suggested this as a possible cause for prolonged
operating time. The largest trial describing the experience with 3,711 stapled hemorrhoidopexies was published recently by Ng et al (2006) [12]. The median operation duration was 15 min (range: 5-45 min), much
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Hemorrhoidectomy versus stapler hemorrhoidopexy

lower than most studies.


In this study, postoperative pain was managed according to the guidelines of the French Anaesthesia
Society. Pain was assessed using a visual analog scale
(VAS). The aim was to keep the VAS score below 3
with adequate analgesia as classified by the World
Health Organization (WHO). Analgesics were administered on the basis of VAS score. Comparison of pain
scores in the two groups of patients was carried out, and
they were maintained below three (3) in all patients.
The pain scores were significantly higher in the open
group at 6 hours, 12 hours, and 24 hours and at first
defecation. Next, comparison of oral medicine and intravenous (IV) injections in the two groups of patients
was conducted. Oral medication necessity was double
in the open group as compared to the stapled group
(5.89/11.04) and the need for IV injections was nearly
triple (1.02/2.89). Similar conclusions were drawn
from previous studies by Tjandra et al. (2007) [9]
that found there was less pain after stapled hemorrhoidopexy as evidenced by lower pain scores at rest and on
defecation and less analgesic requirements. Stolfi et al.
(2008) [10] were also in agreement with this.
In the work presented here, we found that there
was an increased incidence of intraoperative bleeding
in the stapled hemorrhoidectomy group versus the
conventional open group; however, the difference was
not statistically significant. Bleeding occurred in 20%
and 11.1% of patients in the open and stapled groups,
respectively, and the difference was statistically insignificant. Our results were in line with previous studies
conducted by Koh et al. [13] that reported a high incidence of staple line bleeding, up to 44% with various
reasons put forth. When the stapler is deployed in an
intact bowel lumen during the Longo technique, the
stapler actually cuts across well-vascularized tissue, including submucosal blood vessels, under relatively high
pressure. The rectal wall is notoriously vascular, with
vessels situated just beneath the mucosa. Similar intraoperative bleeding results have been noted by Manfredelli et al. [14] that observed a high percentage of staple
line bleeding compared to an open group. In this study,
most of the staple line bleeding was from an active arterial spurt that was managed by electocautery initially
and, if deemed necessary, was controlled by suture rewww.acesjournal.org

inforcement by a figure-of-eight suture. The rest of the


bleedings were ooze-managed by topical hemostats and
gauze packings. We conclude that it is imperative to review the staple line after completion of the procedure
to avoid any bothersome aftereffects from bleeding
of the suture line. At the same time, one considerable
observation of our study was that the amount of blood
loss in the stapled hemmorrhoidectomy group was significantly lower than the open group. The difference
in the amount of blood between the two procedures
was statistically significant. These observations were
similar to previous studies with results that depicted a
similar trend. Only a couple of investigations reported
intraoperative blood loss, each significantly favoring
stapled hemorrhoidopexy (Wilson et al. [15] - 7 versus
39 g, p<.001; Senagore et al. [16] - 26.4 versus 46.9
mL, p=.016). In our study, we found urinary retention
as the most common complication seen in 31.1% and
15.6% of open and stapled patients, respectively; the
difference was statistically insignificant, however. No
postoperative infection was noted in any of the patients
in any of the groups of this study. Moreover, there was
no statistically significant difference in terms of other
postoperative complications. This is similar to findings
of other previous studies (ex. Gravie et al. 2005) [17].
In our study, the mean hospital stay for patients
with stapled hemrrhoidopexy was 1.960.55 days in
comparison to the open group, where the mean hospital stay was 3.510.72 days. The difference was statistically significant with a P-value < 0.001. 80% of patients
were discharged within 2 days from the stapled group,
whereas only 2% were discharged within 2 days from the
open group. Duration of hospital stay was significantly
low in the stapled group with t=11.462; p<0.001. Our
study supports the earlier findings of shorter hospital
stay in patients undergoing stapled hemorrhoidopexy
as reported by Tjandra et al. (2007) [9]; a significant
difference in hospital stay; p<0.0004.
Conclusion
This prospective study confirms that staple hemorrhoidectomy is associated with lower pain scores
postoperatively and shorter durations of postoperative
symptoms in comparison to conventional hemorrhoidectomy. Our study favored staple hemorrhoidectomy
over conventional hemorrhoidectomy with regards
Archives of Clinical and Experimental Surgery

Wani MD et al.

to operative bleeding. Advantages of a circular stapler


in the correction of hemorrhoids are reflected in the
safety, effectiveness, minimal pain and fewer complications than conventional hemorrhoidectomy.
Conflict of interest statement
The authors have no conflicts of interest to declare.
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SAGEYA. This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/
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