Greenblatt 1993.
Methods | Unit of randomisation: ovary Method of randomisation: not stated Time of randomisation: at completion of surgery Blinding: surgeon at second‐look laparoscopy unaware of side that was treated | |
Participants | Patients undergoing bilateral ovarian cautery by laparoscopy
N = 8; 1 exclusion, 7 participants, 14 ovaries
Indication for surgery: infertility due to clomiphene‐resistant PCOS
Pre‐existing adhesions: no
Microsurgery: no Age, mean, years: 26.6 Duration of infertility, mean, years: 3.2 (range 1.5 to 5) Tubal status: normal HSG and laparoscopy Ovulatory status: BBT and serum progesterone Semen analysis: done but results not stated Location: Canada Timing and duration: not stated |
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Interventions | Oxidised regenerated cellulose on ovary vs uncovered opposite ovary Other adjuvants used: none Second‐look laparoscopy
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Outcomes | Adhesions at second‐look laparoscopy: at 3 to 4 weeks
Adverse effects Pregnancy outcomes stated but not by intervention, as unit of randomisation was ovaries |
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Notes | Power calculation: nil Documentation: video Sponsored by MRC Canada (Interceed provided by Johnson & Johnson) No intention‐to‐treat analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement of method of random sequence generation. Quote: "Interceed was applied to one ovary, selected randomly" |
Allocation concealment (selection bias) | Unclear risk | No clear statement of method of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unit of randomisation is ovary, so all women served as their own controls Surgeon was not blinded to intervention. Study authors also do not state whether treatment allocation took place intraoperatively |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessment was performed by an independent blinded surgeon: "three to 4 weeks later, subject returned to the surgical short‐stay unit. They underwent a second laparoscopy performed by a different surgeon, unaware of which side had been wrapped with Interceed" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 exclusion due to technical difficulty in applying oxidised regenerated cellulose |
Selective reporting (reporting bias) | Unclear risk | Data presented as numbers of cases and percentages. P values stated for significant outcomes. No omission of outcomes and no subsets of data. No pre‐published protocol identified |
Other bias | High risk | Study used within‐participant design for reporting adhesion formation. However, study was unclear on presentation and analysis of matched data, and no comparative data were presented. As such, we were unable to extract appropriate data from the study |