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BJOG: an International Journal of Obstetrics and Gynaecology DOI: 10.1111 /j .1471-0528 .2004.0 0430.

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March 2005, Vol. 112, pp. 340 –345

Reducing blood loss at open myomectomy using triple


tourniquets: A randomised controlled trial
A. Taylor,a M. Sharma,a P. Tsirkas,a A. Di Spiezio Sardo,a M. Setchell,b A. Magosa
Objectives To evaluate triple tourniquets in controlled conditions and for the first time to investigate the
hypothesis that leaving a semi-permanent tourniquet around the uterine artery reduces post-operative
bleeding from the uterine incisions.
Design A randomised controlled trial.
Setting Two University teaching hospitals.
Population Twenty-eight patients with symptomatic fibroids and uterine sizes ranging from 14 to 24 weeks of
gestation undergoing open myomectomy.
Methods A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and
polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels. At the
end of the procedure, the ovarian ties were released but the uterine artery suture remained in situ.
Main outcome measures Intra-operative blood loss, post-operative blood loss, blood transfusion rates,
operative morbidity, uterine blood flow and ovarian function.
Results There was significantly less blood lost in the tourniquet group than in the control group
(difference between means 1870 mL, 95% CI 1159 – 2580 mL, P < 0.0001; transfusion rates of 7% and
79%, P ¼ 0.0003). The volume in the pelvic drain 20 min post-operatively and after 48 hours failed to
reach statistical significance between the two groups (P ¼ 0.10 and P ¼ 0.165). There were no
differences in uterine artery Doppler resistance indices at five days (P ¼ 0.54), six weeks (P ¼ 0.47),
three months (P ¼ 0.49) and at six months (P ¼ 0.18). Day two serum FSH concentrations after
surgery were unchanged (P ¼ 0.45), compared with baseline values.
Conclusions Triple tourniquets are effective in reducing bleeding and transfusion rates. There appears no
obvious adverse effect on uterine perfusion or ovarian function.

INTRODUCTION Despite the introduction of new non-surgical techniques,4


where fertility is to be preserved, open myomectomy re-
Improvements in diagnostic imaging reveal that uterine mains the most likely treatment option. In the UK in
fibroids are more prevalent than originally described.1 2001, for instance, 1414 open myomectomies were per-
Recent ultrasound data suggest a cumulative incidence of formed, accounting for 7597 bed days.5 Where future
at least 70% for a woman aged 50 years.2 When symp- fertility is not an issue, hysterectomy remains a common
tomatic, fibroids are associated with reproductive dysfunc- intervention. For all indications, 44,461 hysterectomies
tion, abnormal bleeding and pelvic pressure symptoms. were performed in the same period. Recent data for the
There is also evidence to suggest that fibroids are linked USA show that 37,000 myomectomies are performed
with dyspareunia and non-cyclic pelvic pain.3 annually.6 Open myomectomy is a major surgical proce-
dure and is associated with considerable morbidity, in
particular, operative. One recent study, for instance, re-
ported that 23% patients lost over 1000 mL of blood.7
Other series reported transfusion rates between 18% and
a
Minimally Invasive Therapy Unit and Endoscopy 24%.8 – 10
Training Centre, University Department of Obstetrics Haemostatic tourniquets to reduce intra-operative
and Gynaecology, Royal Free Hospital, Hampstead, bleeding have long been available,11 but data on their
London, UK efficacy from controlled trials are lacking. We set out
b
Department of Obstetrics and Gynaecology, Whittington to evaluate the use of triple tourniquets in controlled
Hospital, Highgate Hill, London, UK conditions and for the first time to investigate the
hypothesis that leaving a semi-permanent tourniquet
Correspondence: Dr A. Magos, Minimally Invasive Therapy Unit and
Endoscopy Training Centre, University Department of Obstetrics and
around the uterine artery reduces post-operative bleeding
Gynaecology, Royal Free Hospital, Pond Street, Hampstead, London, from the uterine incisions, a well-recognised sequel to
NW3 2QG UK. surgery.12 – 14
D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology www.blackwellpublishing.com/bjog
TRIPLE TOURNIQUETS AT OPEN MYOMECTOMY 341

Fig. 1. CONSORT Diagram.

METHODS abnormal uterine bleeding (e.g. menorrhagia, intermenstrual


bleeding) underwent outpatient diagnostic hysteroscopy and
From January 2002 to July 2003, patients seen in the endometrial biopsy.
Fibroid Clinic and Gynaecology Clinic at the Royal Free Pre-operative gonadotrophin releasing hormone agonists
Hospital, and in the Gynaecology Clinic at the Whittington (GnRHa) were only prescribed if the patient was anaemic
Hospital were assessed for entry into this randomised (Hb < 10.5 g/dL), to ensure a pre-operative haemoglobin
controlled trial. Entry criteria were symptomatic fibroids, of >10.5 g/dL, or if uterine size was >20 weeks of ges-
a uterine size equivalent 14 weeks of gestation and tation size (to facilitate the use of a low transverse ab-
requesting myomectomy. Exclusion criteria were a history dominal wall incision).
of a bleeding disorder, concurrent anticoagulant therapy, a The study protocol was approved by the Local Ethics
haemoglobin less than 10.5 g/dL at the time of surgery and Committee (Application No. 5855).
premalignant endometrial histology. Patients were allocated to the control or tourniquet by
Diagnosis of uterine fibroids was based on clinical means of sealed, sequentially numbered opaque envel-
examination and ultrasound scan. Women complaining of opes containing computer-generated random numbers.

Table 1. Patient baseline characteristics. Data are mean (SD), median Table 2. Operative details. Data are mean (SD), median [range] or
[range] or number. number.

Control group Tourniquet group Control group Tourniquet group P


(n ¼ 14) (n ¼ 14) (n ¼ 14) (n ¼ 14)

Age (years) 39.5 (4.7) 42.6 (6.7) Transverse incision (n) 12 14 0.48
Parity 0 [0 – 3] 0 [0 – 3] Operating time (min) 118 (40) 114 (27) 0.74
Pre-operative Hb (g/dL) 11.8 (0.7) 12.2 (0.9) Tourniquet time (min) – 52 (17) –
GnRH analogue pretreatment 1 2 No. of fibroids removed 4.5 [1 – 34] 10.5 [1 – 24] 0.35
Previous surgery 2 3 Weight of fibroids (g) 481 (330) 395 (246) 0.44
Uterine size (weeks) 18 (3.7) 17 (2.4) Blood loss (mL) 2359 (1241) 489 (362) <0.0001

D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology 112, pp. 340 – 345
342 A. TAYLOR ET AL.

Table 3. Post-operative blood loss and transfusion data. Data are mean [SD], median (range), or number (%).

Control group Tourniquet group P


(n ¼ 14) (n ¼ 14)

Volume in drains at 20 min (mL) 20 (5 – 120) 15 (0 – 40) 0.167


Total drained volume at 48 hours (mL) 220 (70 – 320) 150 (0 – 420) 0.165
Fall in haemoglobin at day 2 (g/dL) 2.96 [0.92] 2.79 [0.33] 0.79

No. of patients transfused 11 1 0.0003


Blood (total units) 59 2 0.0005
Fresh frozen plasma (total units) 21 0 0.016
Platelet (total units) 2 0 0.48

Randomisation was done immediately before surgery, occasions 4 hours apart, bowel obstruction, wound infection,
and patients were not informed of their assignment. wound haemorrhage, chest infection and venous thrombo-
All patients underwent a routine open myomectomy embolism), uterine blood flow (assessed by serial measure-
performed by AT, AM or MS based on the technique ments of the resistance index for the uterine artery) and
described by Buttram.1 The default skin incision was a ovarian function (assessed by changes in serum FSH).
suprapubic transverse one. The uterus was exteriorised and Based on a review of the published literature,7,16 we
the bowels packed away using two large wet swabs. We hypothesised that 75% of our control group would lose
tried to use a single midline anterior uterine incision more than 500 mL of blood compared with 25% of the
whenever possible. Blood loss was assessed by weighing tourniquet. For the probability of a type 1 statistical error
swabs and measuring blood collected by suction. Suction (two-sided) to be less than 0.05 and the probability of a
drains were left in situ for 48 hours. All patients received
peri-operative thromboprophylaxis with anti-embolic stock-
ings and heparin, and antibiotic prophylaxis with co-amoxiclav
(Augmentin, GlaxoSmithKline).
Three tourniquets were applied prior to myomectomy,
one to occlude the uterine arteries and two more to occlude
the left and right ovarian vessels. The broad ligament was
opened anteriorly and the bladder reflected inferiorly.
Next, a small opening was made in the avascular space
in the posterior leaf of the broad ligament on either side of
the uterine isthmus superior to the uterine vessels. A
number 1 polyglactin tie was threaded through the two
holes and tied tightly anteriorly around the cervix at the
level of the internal os using a Roeder slip knot which
could be retightened using a laparoscopic knot pusher if
required.
A 20-cm length of narrow bore plastic tubing (we used a
3-mm Westcott anaesthetic anti-syphon set) was used for
the ovarian tourniquets based on the technique described by
Thompson.15 The tubing was passed through the defect in
the broad ligament and looped around the infundibulopel-
vic ligament lateral to the fallopian tube and ovary. The
two ends of the tubing were threaded through a short length
of 24 Fr Foley catheter tubing, which acted as a cushion,
and pulled tight and held with a small clamp to occlude the
ovarian vessels. The procedure was repeated on the con-
tralateral side.
Women in the control group did not receive tourniquets.
Our primary end point was intra-operative blood loss.
Secondary outcome measures included post-operative
blood loss (assessed by surgical drains and changes in
haemoglobin), blood transfusion rates, operative morbidity Fig. 2. Changes in uterine artery Doppler resistance index. Upper panel,
(return to theatre, pyrexia >38°C on more than two controls; lower panel, treatment.

D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology 112, pp. 340 – 345
TRIPLE TOURNIQUETS AT OPEN MYOMECTOMY 343

was significantly greater than in controls (79% compared


with 7%, P ¼ 0.0003) (Table 3).
Episodes of defined post-operative morbidity were sig-
nificantly greater in the control group (8 vs 1 episodes, P ¼
0.0128). The incidence of pyrexia >38°C was the largest
single component of this difference.
There were no significant changes in uterine artery
Doppler resistance indices compared with baseline values
at any of the follow up time points (five days, six weeks,
three months and six months; Fig. 2). Similarly, there was
no significant difference in menstrual cycle day two mean
serum FSH concentrations measured between three and six
months after surgery compared with baseline values in
either the control group (7.2 IU [3.1]) or tourniquet group
(9.2 IU [7.1]) (Fig. 3).

DISCUSSION

For the first time in controlled conditions, we have shown


that triple tourniquets applied to the uterine and ovarian
vessels significantly reduce operative blood loss, the need
for blood transfusion and peri-operative morbidity at open
myomectomy. Although we did not find a statistically
significant benefit to leaving the absorbable uterine tourni-
quet in situ after the myomectomy, this was not a primary
end point and our study proved underpowered for this
outcome. Reassuringly, the tourniquets did not appear to
Fig. 3. Changes in serum FSH concentration. Upper panel, controls; lower affect subsequent ovarian function. As our study was
panel, treatment group.
inclusive rather than exclusive (by including patients who
had undergone previous laparotomy, including previous
type 2 error to be less than 0.2, we calculated that we myomectomy), these results are as generalisable as possible.
would need 14 patients in each group, giving a total of Temporary haemostatic occlusion of the uterine blood
study size of 28 women. supply at open myomectomy was first achieved using metal
Data were analysed using t test (paired and unpaired), clamps17 and evolved from earlier practices of caustic
Mann – Whitney U test, Wilcoxon signed rank test and packs18 and ligation of the uterine arteries.19 In the original
Fisher’s exact test using GraphPad Prism 4 software description, both the uterine arteries and the ovarian vessels
(GraphPad Software, San Diego, California, USA). We were occluded. This technique of total vascular occlusion
assumed significance at the 5% level (P < 0.05). of the uterine blood supply is still taught today.15 Our study
evaluated triple tourniquets against a control group. In the
future, it would be interesting to evaluate triple tourniquets
RESULTS against the practise of using a single tourniquet.20
Chemical tourniquets using vasopressin have also been
The 28 patients were recruited from a cohort of 171 described.7,9 One randomised controlled trial comparing
patients referred to hospital for management of moderately intramyometrial vasopressin with uterine tourniquet did
enlarged uterine fibroids. Of the 30 women for whom open report a significant advantage to the former, but ovarian
myomectomy was judged appropriate, one patient was ex- tourniquets were not applied, the uterine tourniquet was
cluded because of anaemia due to thalassaemia, and released every 20 min, and most importantly, blood loss in
another declined to be randomised (Fig. 1). The two ran- swabs was not included in the estimation of operative
domisation groups were similar in baseline characteristics, blood loss.7 Another trial utilised occlusion of both the
including uterine size (Table 1). uterine and ovarian vessels and reported no difference with
The operative details are summarised in Table 2. All vasopressin.9 It seems, therefore, that triple tourniquets are
myomectomies were completed successfully. Mean intra- effective as vasopressin injection, but without the risks of
operative bleeding was 1870 mL greater in the control the latter.21 – 23
group compared with those given tourniquets (95% CI While intra-operative blood loss in the tourniquet group
1159 – 2580 mL). The transfusion rate in the control group was broadly comparable to previously published data, the
D RCOG 2004 BJOG: an International Journal of Obstetrics and Gynaecology 112, pp. 340 – 345
344 A. TAYLOR ET AL.

results in the control group were considerably in excess of did not appear to be any significant changes observed
what we expected based on a review of the literature. One compared with pre-operative levels. We accept that this is
explanation could be the use of different methods of blood short term data and propose a longer term follow up of
loss collection and estimation as discussed earlier. Another gonadotrophins. Similarly, as for the uterine blood flow
reason for this discrepancy might be differences in the outcomes, the study was not specifically powered to ex-
amount of fibroid tissue removed. Previously published clude an effect on ovarian function and our study might
series do not to include data on the weight of fibroids re- have been underpowered to determine this. However,
moved, and yet it is known that estimation of uterine size reassuringly though, the first patient in the tourniquet group
is only a rough estimate of uterine weight and therefore has recently given birth, having had an uncomplicated full-
fibroid weight. One study, for instance, found that a term pregnancy. This is consistent with data from hetero-
uterus, which on bimanual examination feels equivalent topic autotransplantation in the ewe (an accepted model in
to 20 weeks of gestation, has on average weight of about reproductive endocrinology) which suggests that there is
1000 g, but with a standard deviation of over 500 g.24 As only minimal injury to tissue even after 3 hours of ovarian
intra-operative bleeding is proportional to the amount of vascular occlusion.33
fibroid tissue removed, differences in fibroid weight can In summary, our results clearly demonstrate the effec-
account for major differences in blood loss data.9 tiveness of triple tourniquets and we would strongly advo-
In our study, we chose only to use pre-operative GnRHa cate their routine use at open myomectomy as a safe and
under certain well-defined conditions. Although such pre- convenient alternative to other haemostatic techniques.
treatment can be effective in reducing blood loss at open
myomectomy,25 these drugs are expensive, are associated
with oestrogen deficient side effects, can make the surgery
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