Sekiba 1992.
Methods | Unit of randomisation: pelvic sidewall
Method of randomisation: sealed envelopes
Time of randomisation: at completion of surgery
Blinding: double 63 participants (126 pelvic sidewalls) No exclusions stated Trial supported by manufacturers of Interceed (Johnson & Johnson Medical, KK, Tokyo, Japan) |
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Participants | Participants undergoing adhesiolysis by laparotomy
N = 63 Dropouts: not stated Indication for surgery: infertility, known presence of bilateral sidewall adhesions Pre‐existing adhesions: yes Cause of adhesions: severe endometriosis 28; previous surgery 15; PID 9; no obvious cause 19 Microsurgery: no Country: Japan Timing and duration: not stated |
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Interventions | Oxidised regenerated cellulose on pelvic sidewall vs uncovered opposite sidewall Other adjuvants used: none Second‐look laparoscopy
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Outcomes | Adhesions at second‐look laparoscopy at 10 days to 14 weeks
Pregnancy outcomes: nil |
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Notes | Documented with photographs and drawings
No power calculations
Duplicate publication
Supported by Johnson & Johnson
Multi‐centre trial Trial also published elsewhere in 1993 (see references) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement provided regarding method of randomisation |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes used for allocation concealment but unclear when sealed or opened. Quote: "the pelvic sidewall to be covered was determined randomly using sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unit of randomisation was right or left pelvic sidewall, so every woman also acted as her own control Not clearly stated whether surgeon was blinded, or when treatment allocation was revealed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessor performing second‐look laparoscopy was blinded to allocation |
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 presented in graphical form for some outcomes. P values stated for significant outcomes. No data subsets reported. No pregnancy outcomes reported despite being an infertility study |
Other bias | Low risk | No other bias identified |