Myomectomy ASG 1995.

Methods	Unit of randomisation: myomectomy site Method of randomisation: computerised randomisation table ‐ sealed envelopes Timing of randomisation: at completion of surgery Blinding: not stated whether surgeon was aware of randomisation at second‐look laparoscopy
Participants	Patients undergoing myomectomy (2 or more) by laparotomy N = 28 1 exclusion (declined second‐look laparoscopy) 27 participants (54 myomectomy sites) analysed All had 2 myomectomy incisions of similar length and > 2 cm apart located on the fundus and on the posterior uterine wall Indication for surgery: fibroids; not exclusively participants with infertility Microsurgery: no Pre‐existing adhesions: no Age, years, range: 18 to 43 Location: USA (Durham, North Carolina; Houston, Texas; Atlanta, Georgia; San Diego, California) and Canada (Montreal) Timing and duration: 1991 to 1993
Interventions	Expanded polytetrafluoroethylene over myomectomy site vs uncovered myomectomy site Other adjuvants used: antibiotics Second‐look laparoscopy Timing: 2 to 6 weeks after initial surgery (mean 25 days) Surgeon unaware: not stated Adhesiolysis: yes
Outcomes	Adhesions at second‐look laparoscopy: 2 to 6 weeks after initial surgery Incidence (per myomectomy site) Extent: area Adhesion score Area: measured (not specified) Scoring (0 to 11) according to (1) extent: 0 = no adhesions; 1 = < 25%; 2 = 25% to 50%; 3 = 50% to 75%; 4 = > 75%; (2) type: 0 = none; 1 = filmy, transparent, avascular; 2 = opaque, transparent, avascular; 3 = opaque, capillaries present; 4 = opaque, large vessels; (3) tenacity: 0 = none; 1 = adhesions essentially fell apart; 2 = adhesions were lysed with traction; 3 = adhesions required sharp dissection Adverse effects Pregnancy outcomes: nil
Notes	Documented with diagrams, photographs, and videotapes Sponsored by Gore‐Tex Surgical Membrane Multi‐centre trial Power calculations: nil Preliminary reports of this trial published as abstracts 1993 and 1994 No intention‐to‐treat analysis
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation performed using a computerised randomisation table
Allocation concealment (selection bias)	Low risk	Assignments were concealed in sealed envelopes opened intraoperatively
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	No clear statement whether initial surgeon or participants were blinded
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No clear statement whether surgeon performing second‐look laparoscopy or assessment at SLL was blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	One participant withdrew from study before SLL
Selective reporting (reporting bias)	Unclear risk	Data presented as incidence of adhesions with CI and adhesion scores as means ± SEM. P values reported. No omissions or subsets of data. However, no pre‐published protocol identified
Other bias	Low risk	No other bias identified