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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre non‐inferiority RCT
Computer‐generated random number list
Allocation at inclusion with surgeon aware only in operating theatre
Envelopes allocation
Sample size: 35 in each group, 80% power to detect 5% significant change with 10% drop‐out
ITT analysis
Assessors blinded
Women unblinded
Participants Any anterior POP point Ba ≥ +1 on POPQ
Excluded malignant urogenital disease, prior radiation, acute genitourinary infection, connective tissue disorders, steroid treatments, insulin‐dependent diabetes
Interventions All procedures under spinal by 3 experienced surgeons
1. AC: plicate fascia purse string 0 polyglactin (Vicryl), vaginal trimming, transvaginal trocar‐guided polypropylene mesh (kits donated by Promedon) Nazca TC (Promedon, Córdoba, Argentina) I prepubic and 2 transobturator macroporous monofilament; vagina closed overlapping fashion
355 accessed, 79 randomised
AC 39 completed, 1‐year review n = 39
2. Anterior mesh 40 randomised, 40 completed 1‐year review
Concomitant surgery as required
Outcomes Assessed at 1 year
Reports the following review outcomes:
  • Awareness of prolapse: positive answer to at least 1 PQOL question on vaginal bulge, pelvis pain, sensation of prolapse (unusual combined measure ‐ data not used)

  • Mesh exposure

  • Bladder injury

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

  • Sexual function: de novo dyspareunia

  • Operating time

  • Blood transfusion

  • Days in hospital

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Random sequence generation tables
Allocation concealment (selection bias) Unclear risk Envelopes (opaque?, sealed?)
Blinding of participants and personnel (performance bias) All outcomes High risk Non‐blinded
Blinding of outcome assessment (detection bias) All outcomes Low risk Blinded assessors
Incomplete outcome data (attrition bias) All outcomes Low risk 79 randomised, and all completed 1‐year review
Selective reporting (reporting bias) Unclear risk Did not clearly report any of the primary outcomes of this review
Other bias Low risk Funded by Federal University of Sao Paulo, Brazil; Promedon contributed product free of charge
No author COI