Methods | Single‐centre RCT for stage 2 POPQ prolapse PC‐generated randomisation 2‐year follow‐up No CONSORT statement Blinding not stated Authors state power of 85% need sample size of 20 in each arm |
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Participants | 40 randomised in abstract, however 44 were randomised, 4 of whom failed to
return postoperatively and were excluded Inclusion criteria: stage 2 POPQ cystocele with no plans of pregnancy in 12 months Exclusion criteria: contemplating pregnancy, women with paravaginal defects, needing continence surgery, prior colposuspension or vaginal surgery, immunocompromised, or diabetics |
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Interventions | A (n = 23): anterior colporrhaphy AC 0 polyglactin (Vicryl) suture B (n = 21): self styled armless soft polypropylene (Gynemesh) mesh without AC |
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Outcomes | Assessed at 6 weeks, 3 months, then every 6 months to 2 years postop 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 number tables |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes to ensure allocation concealment; as not consecutive sealed, opaque envelopes unclear |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Reviewers blinded except when mesh exposure occurred |
Incomplete outcome data (attrition bias) All outcomes | Low risk | At 1‐year, group A 20/23, group B 20/21 |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | Unclear risk | Funding not stated; authors no COI |