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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT India
Computer‐generated randomisation
Allocation concealment: not stated
Blinding of participants and reviewers: not stated
Sample size 106 with 80% power to detect 21% difference between the groups with 5% type 1 error
Participants Inclusion criteria: stage 2 or greater anterior compartment prolapse
Exclusion criteria: SUI, dominant post‐vaginal prolapse, suspected malignancy, vaginal infections
Interventions Group A: AC 2.0 polyglactin (Vicryl); n = 54, 1 year n = 41
Group B: self‐styled 4‐arms monofilament polypropylene mesh (Vypro mesh, J&J); n = 52, 1 year n = 44
Outcomes Assessed at 6 months, 1 year
Reports the following review outcomes:
  • Awareness of prolapse (vaginal bulge) at 1 year

  • Repeat prolapse (anterior)

  • Mesh erosion

  • Surgery for mesh exposure

  • Objective failure of anterior compartment (cystocele)

  • Operating time

  • Blood transfusion

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk No statement
Blinding of participants and personnel (performance bias) All outcomes Unclear risk No statement
Blinding of outcome assessment (detection bias) All outcomes Unclear risk No statement
Incomplete outcome data (attrition bias) All outcomes High risk Gp A 41/54, Gp B 44/52 at 1 year (20% attrition)
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias Unclear risk No COI statement