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. 2020 Mar 22;2020(3):CD000475. doi: 10.1002/14651858.CD000475.pub4

Mais 1995b.

Methods Unit of randomisation: participant
 Method of randomisation: random numbers table ‐ numbered sealed envelopes
 Time of randomisation: at completion of surgery
 Blinding: double
Participants Patients undergoing myomectomy by laparoscopy
 N = 50
 Dropouts: nil
 Myomectomy consisted of removal of 1 to 4 myomas; largest was 3 to 6 cm
Indication for surgery: fibroids; not specifically participants with infertility
 Pre‐existing adhesions: no
 Microsurgery: no
Age, years, mean (SD): treatment group 34.1 (5.7); control group 33.2 (5.5)
Location: Italy
 Timing and duration: January 1993 to June 1994
Interventions Oxidised regenerated cellulose on myomectomy incision(s) vs uncovered myomectomy site(s)
Other adjuvants used: none
Second‐look laparoscopy
  1. Timing: 12 to 14 weeks after initial surgery

  2. Surgeon unaware: yes

  3. Adhesiolysis: not stated

Outcomes Adhesions at second‐look laparoscopy 12 to 14 weeks later
  1. Incidence (per participant)

  2. Severity: graded as filmy and avascular, dense and/or vascular, or cohesive


Adverse effects
Pregnancy: not stated
Notes Power calculations: nil
 Documentation: not stated
 No source of funding stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Treatment or control assignment was obtained by using a table of random digits
Allocation concealment (selection bias) Low risk Numbered, sealed envelopes were used to conceal allocation. The envelope seal was broken in the operation room after completion of all operative procedures and before removal of laparoscopic ports
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Does not state whether initial surgeon was blinded; however as control was no treatment, appears unlikely that they were. Not clearly stated whether participants were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Independent blinded surgeons performed second‐look laparoscopy
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No mention of whether withdrawals or dropouts occurred during the study
Selective reporting (reporting bias) Unclear risk Data reported in incidences/percentages. No range or CI reported. P values reported only for significant results. No conversion of data or subsets
Other bias Low risk No other bias identified