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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
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
Outcomes Assessed at 2, 6, 12 weeks and 1 year
Reports the following review outcomes at 1 year:
  • Recurrent prolapse (grade 2 or 3 cystocele or rectocele using BW scale)

  • Mesh erosion (no events)

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