Methods | Single‐centre RCT (computer‐generated number table) Vaginal repair with or without polyglactin (Vicryl) mesh overlay for cystocele and rectocele Follow‐up: Gp A 12 months, Gp B 12 months | |
Participants | 143 women Inclusion: cystocele to or beyond hymenal ring on standing Exclusion: less than 18 years of age, pregnancy, contemplating pregnancy within 1 year, paravaginal defect only, anterior enterocele 161 randomised 1 excluded (anterior enterocele) 17 lost to follow‐up | |
Interventions | Gp A (70): no mesh: Vicryl plication of anterior endopelvic
fascia Gp B (73): mesh: as above with Vicryl mesh folded
underneath trigone and cuff and secured Vicryl to fascia; also added to
posterior wall if posterior repair performed Posterior repair
performed: A: 67/70, B: 65/73 Standardised concomitant surgery Review by surgeon |
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Outcomes | Assessed at 2, 6, 12 weeks and 1 year Reports the following review outcomes at 1 year:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation list |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 143/170 (84%) completed 1‐year review |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | Unclear risk | No COI statement |