Methods | Single‐centre RCT (computer‐generated, opaque envelopes, adequate concealment) AC with and without fascia lata for primary or recurrent anterior vaginal wall prolapse | |
Participants | 162 signed consent form 154 randomised A 76, B 78 Loss to follow‐up 2 in B, but in results 78 and 77 analysed respectively Inclusion: anterior vaginal wall prolapse to hymen or beyond on straining; > 18 years of age; willing to comply with return visits Concomitant surgery: vaginal hysterectomy in 49%/47%; sacrospinous fixation in 43%/42% (all cases with vaginal vault prolapse to mid‐vagina or beyond); posterior repair in 99%/94%; Coopers' ligament sling in 67%/55%; mid‐urethral sling 13%/10% Enterocele: A 75%, B 73% Baseline voiding dysfunction (slow stream): A 48/68, B 42/65 | |
Interventions | A (76): "ultra‐lateral" midline plication of anterior endopelvic connective tissue using polyglactin (Vicryl) buttress sutures (as described by Weber 2001), plus additional cadaveric fascia lata patch (Tutoplast) anchored at the lateral limits of the colporrhaphy B (78): as above without allograft | |
Outcomes | Assessed at 1 year Reports the following review outcomes:
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Notes | Unclear participant numbers (disparity with loss to follow‐up) Questionnaires not used in all participants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Low risk | Sealed, opaque, consecutive envelopes |
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 | Low risk | Data largely complete; 2/155 lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | Unclear risk | No COI or funding statement |