Methods

RCT. Randomisation was determined using a computer‐based method. The groups were comparable at entry. There was no exclusion after allocation and no withdrawal. Weekly abdominal and pelvic ultrasound was performed on 110 of 137 women to detect lymphocyst formation.

Participants

Women with FIGO stage I‐IV ovarian carcinoma (43 women), stage IB‐III cervical carcinoma (45 women), and stage I‐II endometrial carcinoma (49 women). The women underwent intensive surgical staging/tumour reductive surgery/second‐look laparotomy (ovarian carcinoma) or Piver type I/II radical hysterectomy (endometrial carcinoma) or Piver type III/IV radical hysterectomy (cervical carcinoma) plus bilateral pelvic or pelvic and para‐aortic lymphadenectomy.

Study setting: the Catholic University of Rome and the Hospital San Carlo di Nancy, Rome, Italy

Interventions

Women were randomised intraoperatively to the use of drains (68 women) or no drain (69 women). For those randomised to drains, 2 retroperitoneal low‐pressure closed‐suction drains were placed. For pelvic/para‐aortic lymphadenectomy, the first drain was placed at the insertion of the mesenteric artery down to the left external iliac artery, and the second drain at the level of the paracaval area from the point where the ovarian vein enters the cava down to the right external iliac artery. For pelvic lymphadenectomy, the cranial part of the drains was at the level of the ipsilateral common iliac vessels. The drains were removed when the loss was less than 50 mL in 24 hours.

Outcomes

There was a significant increase in complications (43% versus 22%) in the drain group, mainly related to lymphocyst. The hospital stay was shorter in the group not drained.

Notes

In all cases, the pelvic peritoneum and the peritoneum along the paracolic gutters were left open.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

It was stated that "Randomization was centralized and computer‐based."

Allocation concealment (selection bias)

Low risk

It was stated that "Randomization was centralized and computer‐based." The allocation concealment was probably adequate.

Blinding (performance bias and detection bias)
Lymphocyst formation

Low risk

Weekly ultrasound pelvic and abdominal examinations were performed; the ultrasound operator was unaware of the ongoing study.

Blinding (performance bias and detection bias)
Postoperative morbidities and recovery

Unclear risk

The blinding of participants, treatment providers, and outcome assessors was not documented.

Incomplete outcome data (attrition bias)
Short‐term lymphocyst formation

Low risk

It was stated that the weekly ultrasound examinations to detect lymphocyst formation were performed on 110 women operated on at the Catholic University (of 137 women in the study).

Selective reporting (reporting bias)

Unclear risk

The rate of asymptomatic lymphocyst formation was not specifically addressed.

Methods

Multicentre RCT (12 European cancer centres). Randomisation was determined using a computer‐based method. Stratification was performed per centre. The groups were comparable at entry. There was no exclusion after allocation and no withdrawal. Ultrasonography or CT scan was performed at 1 and 12 months postoperatively on all women to identify lymphocyst formation.

Participants

Women with FIGO stage IA1‐IIA cervical carcinoma (198 women), endometrial carcinoma (35 women), and vaginal carcinoma (1 woman). All had radical hysterectomy and bilateral pelvic lymphadenectomy.

Study setting: European cancer centres (the EORTC trial)

Interventions

Women were randomised following surgery to either pelvic drainage (117 women) or no drainage (117 women). For those randomised to drains, 2 passive or active suction drains were placed in the retroperitoneal fossa and inserted via the vagina or the abdominal route, according to the institution's policy. The drains were removed when the loss was less than 50 mL in 24 hours.

Outcomes

The study found no difference in the incidence of postoperative lymphocyst formation or postoperative complications between the 2 groups. The late (12 months) incidence of symptomatic lymphocysts was 5.9% in the drain group versus 0.9% in the no‐drain group (P = 0.06).

Notes

In all cases, the vaginal cuff was primarily closed and the pelvic peritoneum was left open.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Blinding (performance bias and detection bias)
Postoperative morbidities and recovery

Unclear risk

The blinding of participants, treatment providers, and outcome assessors was not documented.

Incomplete outcome data (attrition bias)
Short‐term lymphocyst formation

Low risk

Methods

RCT. Randomisation was determined using a random number table. The groups were comparable at entry. There was no exclusion after allocation and no withdrawal. An abdominal ultrasound scan was performed approximately 8 weeks after the surgery to identify any asymptomatic Iymphocysts.

Participants

Women with FIGO stage IA‐IIB cervical carcinoma (95 women) and stage IIB endometrial carcinoma (5 women). All had Piver type II radical hysterectomy and bilateral pelvic lymphadenectomy.

Study setting: Regional Department of Gynaecological Oncology, Gateshead, United Kingdom

Interventions

Women were randomised immediately before abdominal closure to the use of drains (51 women) or no drain (49 women). For those randomised to drains, 2 suction drains were inserted, 1 through each iliac fossa, and placed alongside the site of node dissection. The drains were usually removed when the loss was less than 100 mL in 24 hours.

Outcomes

The detection of lymphocysts by ultrasound and clinical examination in the drains group (15.6% and 5.9%, respectively) did not differ significantly from the group not drained (17.4% and 6.1%, respectively). Postoperative morbidity did not differ between the groups.

Notes

In each case, the vaginal cuff edge was oversewn, leaving the vaginal vault open, and the pelvis was not reperitonised.

Of the 100 women randomised, 8 defaulted their ultrasound scan: 5 were in the drained group and 3 were not. Of these 8, 2 (1 in each group) were assessed further; 1 had a magnetic resonance imaging scan and another had a laparotomy, both showing no evidence of lymphocysts.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Randomisation was determined using a random number table.

Allocation concealment (selection bias)

Low risk

The random allocation was done using numbered envelopes kept in the operating theatre. The allocation concealment was probably adequate, although the authors did not specifically mention whether or not the envelopes were sealed and opaque.

Blinding (performance bias and detection bias)
Lymphocyst formation

Unclear risk

An abdominal ultrasound scan was performed approximately 8 weeks after surgery to identify any asymptomatic lymphocysts. Also, the clinical detection of lymphocysts at subsequent review visits was documented. However, any attempt to blind outcome assessors was not mentioned.

Blinding (performance bias and detection bias)
Postoperative morbidities and recovery

Unclear risk

The blinding of participants, treatment providers, and outcome assessors was not documented.

Incomplete outcome data (attrition bias)
Short‐term lymphocyst formation

Low risk

It was stated that "Of the 100 women randomized, eight defaulted their ultrasound scan; five were in the drained group and three were not." Also, it was stated that "the scan was reported as unsatisfactory in one patient who had been drained."

Selective reporting (reporting bias)

Low risk

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Methods

RCT. Randomisation was conducted by block randomisation. The groups were comparable at entry. There was no exclusion after allocation and no withdrawal. Transabdominal and transvaginal ultrasound were performed at 4, 8, and 12 weeks after surgery to detect lymphocyst formation.

Participants

Women with FIGO stage IA2‐IIA cervical carcinoma (100 women). All had Piver type II/III radical hysterectomy and bilateral pelvic lymphadenectomy.

Study setting: Chiang Mai University Hospital, Chiang Mai, Thailand

Interventions

Women were randomised immediately before abdominal closure to the use of drains with closure of pelvic peritoneum (52 women) or no drain with pelvic peritoneum left open (48 women). For those randomised to drains, 2 low‐pressure closed‐suction drains were placed along the side of node dissection and brought out extraperitoneally through the anterior abdominal wall lateral to the rectus muscle margins. The drains were removed when the loss was less than 50 mL in 24 hours.

Outcomes

Asymptomatic lymphocysts were sonographically detected at 4, 8, and 12 weeks postoperatively in 6.8%, 4.6%, and 7.7% of women, respectively, in the group not drained, whereas none were found in the drain group (P = 0.2). Postoperative morbidity did not differ significantly between the 2 groups.

Notes

The vaginal vault was primarily closed in all cases.

Of the 52 women in the drain group, 50, 46, and 44 women had ultrasound done at 4, 8, and 12 weeks after surgery, respectively, as scheduled. Of the 48 women in the no‐drain group, 44, 43, and 39 women underwent ultrasound examination at each scheduled visit.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The method of block randomisation was used.

Allocation concealment (selection bias)

Low risk

The random allocation was done using sealed, numbered envelopes kept in the operating theatre.

Blinding (performance bias and detection bias)
Lymphocyst formation

Low risk

The operators of transabdominal and transvaginal ultrasound to detect lymphocyst formation were not aware of the group allocation.

Blinding (performance bias and detection bias)
Postoperative morbidities and recovery

High risk

The participants, treatment providers, and outcome assessors were not blinded.

Incomplete outcome data (attrition bias)
Short‐term lymphocyst formation

Low risk

The number of participants who had postoperative ultrasound performed at each visit as scheduled was reported. Accordingly, the number of missing cases was known.

Selective reporting (reporting bias)

Low risk

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