Menefee 2011.
Methods | Double‐blinded triple‐arm RCT Randomisation, allocation concealment, NS power, 33 in each group, 80% power to detect 35% difference with 5% type 2 error 2‐Year review |
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Participants | Inclusion: women ≥ 18 years of age with a POPQ point Ba ≥ 0 Exclusion: NS Concomitant surgery: hysterectomy, colpopexy, posterior repair, continence at surgeon's discretion |
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Interventions | 99 randomised A (32): standard anterior colporrhaphy using midline plication with delayed absorbable suture B (31): vaginal paravaginal repair using free‐hand formed porcine dermis graft (Pelvicol) C (36): vaginal/paravaginal repair using free‐formed polypropylene mesh (M). All graft material was secured to the arcus tendineus fascia pelvis by a Capio device with permanent monofilament suture |
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Outcomes | Assessed at 2 years Reported the following review outcomes at 2 years
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated sequence |
Allocation concealment (selection bias) | Low risk | Opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Moderate attrition 1 year: AC 24/32 (75%) ‐ porcine 26/31 (84%), mesh 28/36 (77%) |
Selective reporting (reporting bias) | Low risk | Significant outcome data |
Other bias | High risk | Study authors reported COI with companies producing product evaluated; funding by Boston Scientific, whose product Capio was being evaluated |