Methods | Single‐centre RCT India Computer‐generated randomisation Allocation concealment: not stated Blinding of participants and reviewers: not stated Sample size 106 with 80% power to detect 21% difference between the groups with 5% type 1 error |
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Participants | Inclusion criteria: stage 2 or greater anterior compartment prolapse Exclusion criteria: SUI, dominant post‐vaginal prolapse, suspected malignancy, vaginal infections |
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Interventions | Group A: AC 2.0 polyglactin (Vicryl); n = 54, 1 year n = 41 Group B: self‐styled 4‐arms monofilament polypropylene mesh (Vypro mesh, J&J); n = 52, 1 year n = 44 |
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Outcomes | Assessed at 6 months, 1 year Reports the following review outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | No statement |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No statement |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No statement |
Incomplete outcome data (attrition bias) All outcomes | High risk | Gp A 41/54, Gp B 44/52 at 1 year (20% attrition) |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | Unclear risk | No COI statement |