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 |
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| Interventions | Oxidised regenerated cellulose on myomectomy incision(s) vs uncovered myomectomy site(s) Other adjuvants used: none Second‐look laparoscopy
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| Outcomes | Adhesions at second‐look laparoscopy 12 to 14 weeks later
Adverse effects Pregnancy: not stated |
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| 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 |