Keckstein 1996.
Methods | Unit of randomisation: ovary
Method of randomisation: toss of a coin
Time of randomisation: at completion of surgery Blinding: surgeon at second‐look laparoscopy not aware of allocation |
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Participants | Patients undergoing bilateral ovarian cystectomy by laparoscopy N = 25 14 participants with bilateral endometriomas, 6 with ovarian cysts and endometriosis, and 5 with ovarian cysts only Dropouts: 8, not stated why Some participants also underwent adhesiolysis and removal of endometriosis Indication for surgery: ovarian cysts; not specifically participants with infertility Pre‐existing adhesions: some (but participants with dense adhesions excluded) Cause of adhesions: not stated (endometriosis included) Microsurgery: no Timing not stated Country: Germany (1 centre) |
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Interventions | Oxidised regenerated cellulose on ovary vs uncovered opposite ovary Other adjuvants used: none Suturing: 9 of 17 in the oxidised regenerated cellulose group; 3 of 17 in the non‐oxidised regenerated cellulose group Second‐look laparoscopy
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Outcomes | Adhesions at second‐look laparoscopy: 8 to 30 weeks
Adverse effects Pregnancy data nil |
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Notes | Power calculations: nil Analysis sponsored by Johnson & Johnson only after study was completed First presented as abstract in 1994 No photographic or video documentation No intention‐to‐treat analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin tosses were used as a simple method of randomisation Quote: "the random assignment of one ovary for wrapping with Interceed was revealed to the surgeon after a coin toss" |
Allocation concealment (selection bias) | Low risk | Coin toss took place intraoperatively |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Unit of randomisation was each ovary, so all women acted as their own controls Surgeon was not blinded, but treatment allocation took place intraoperatively: "at the end of cystectomy the random assignment of one ovary for wrapping with Interceed [...] was revealed to the surgeon after a coin toss" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study does not state whether the assessor during SLL was blinded to initial treatment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 8 dropouts (n = 25); no reasons stated as to why participants did not return for SLL |
Selective reporting (reporting bias) | Unclear risk | Data presented as numbers of cases and percentages, as well as graphically. P values stated for significant outcomes. No omission of outcomes and no subsets of data. However, no pre‐published protocol identified |
Other bias | Low risk | No other bias identified |