Saravelos 1996.
Methods | Unit of randomisation: ovaries Method of randomisation: computer‐generated in opaque envelopes Timing of randomisation: unclear Blinding: double | |
Participants | Women (N = 21) undergoing treatment for polycystic ovarian syndrome by ovarian electrocautery
7 dropouts: 4 were pregnant, 2 withdrew, 1 had such dense adhesions at laparoscopy of both ovaries that no assessment could be made Pre‐existing adhesions: nil Mean age, years: 28 No other cause for infertility found Timing: 1994 to 1995 Country: UK (1 centre) |
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Interventions | Oxidised regenerated cellulose vs no treatment | |
Outcomes | Adhesion formation
Further adhesiolysis Timing of second‐look laparoscopy: 2 to 11 weeks Pregnancy: outcomes given but ovaries randomly assigned, not participants |
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Notes | Supported by Johnson & Johnson Video taken Power calculations: nil No intention‐to‐treat analysis | |
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: "a sealed envelope disclosed the assignment of which side was to be treated with Interceed" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unit of randomisation was right or left ovary, 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 | Second‐look laparoscopy was video‐recorded and assessed by independent blinded assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 1 participant excluded, as underwent ovarian drilling; 4 withdrew because of pregnancy; 2 withdrew because of personal choice (n = 21) |
Selective reporting (reporting bias) | Unclear risk | Data reported as incidences and percentages. No data conversion. No P values reported |
Other bias | Low risk | No other bias identified |