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. 2016 Feb 9;2016(2):CD012079. doi: 10.1002/14651858.CD012079
Methods Single‐centre RCT
Computer‐generated randomisation and allocation concealment were appropriate with sealed envelopes opened in operating room
Reviews by non‐blinded surgeon
No concomitant surgery
80% power to detect 20% difference between the groups with 5% type 1 error: 60 randomised
Participants Inclusion criteria: symptomatic prolapse point Ba ≥ ‐1
Exclusion criteria: defects posterior or apical compartment, prior pelvic surgery, history of collagen or endocrine disorders
Allocated: Gp A 31, Gp B 30
1 year: Gp A 26, Gp B 28
Interventions A (31): 2.0 interrupted polyglactin (Vicryl) plication
B (30): no plication, Pelvicol porcine dermis 4 x 7 cm anchored with 2.0 polyglactin (Vicryl) sutures
No concomitant surgery
Outcomes Assessed at 1 year
Reports the following review outcomes:
  • Repeat prolapse surgery

  • Awareness of prolapse (vaginal bulging or lump)

  • Recurrence of prolapse (POPQ Ba ≥ ‐1.0)

  • Repeat surgery for incontinence

  • Objective failure of anterior compartment

  • POPQ assessment of prolapse: pt Ba at 12 months (states median and range)

  • Quality of life: King's Health Questionnaire (graphical results and P values only)

  • Operating time

Notes Irregularities exist: methods failure defined as e Ba ≥ ‐1 results > ‐1;
in table 2 Gp A range Ba 2 to 8, and states in table 3 that 4 had stage 2 prolapse
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 Sealed, non‐transparent, consecutive envelopes
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias) All outcomes High risk Reviewers not blinded, participant‐completed questionnaires
Incomplete outcome data (attrition bias) All outcomes Low risk 1 year: Gp A 26/31, Gp B 28/30 (88%)
Selective reporting (reporting bias) Low risk Reports main review outcomes
Other bias Unclear risk No COI declared; no statement funding