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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT
Randomisation and allocation concealment described
Evaluated 1 year after AC as compared to small intestine submucosa graft
Blinded reviewers
Sample size of 60 women was required to achieve a significance level of 0.05 and a power of 80%. This was based on the assumptions of a 25% difference in cure rates between the groups with a 10% loss to follow‐up rate
Participants Inclusion criteria: women with point Ba ≥ ‐1
Exclusion criteria: hypertension, prior radiation, pelvic sepsis, diabetes, and chronic illness
Concomitant surgery allowed including vaginal hysterectomy if greater than stage 2 uterine prolapse
Interventions Gp A (27) AC with interrupted 0 polyglactin (Vicryl) sutures
GP B (29) non‐cross‐linked xenograft porcine small intestine submucosa 7 x 10 cm with dissection to suprapubic arch fixed with 0 prolene x3 each side
Outcomes Assessed at 1 year
Reports the following review outcomes at 1 year:
  • Repeat prolapse surgery (no events)

  • Recurrent prolapse (at point Ba)

  • Mesh exposure (no events)

  • Dyspareunia (any ‐ no separate data for de novo)

  • POPQ assessment of prolapse: point Ba, C, Bp, total vaginal length

  • Quality of life: PQOL questionnaire end scores

  • Operating time

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) Low risk Centrally controlled allocation concealment appropriate
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias) All outcomes Low risk Blinded reviewers and participant‐completed validated questionnaires
Incomplete outcome data (attrition bias) All outcomes High risk 1 year: Gp A 20/27(74%); Gp B 22/29 (76%)
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias Low risk No COI and no external funding