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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
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:
  • Awareness of prolapse (vaginal bulging)

  • Recurrent prolapse (POPQ stage 2 anterior prolapse)

  • Objective failure of anterior compartment (same data as recurrent prolapse)

  • Bladder function: postvoid fullness

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