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. 2018 Mar 5;2018(3):CD012975. doi: 10.1002/14651858.CD012975

Glazener 2017.

Methods RCT: 2 parallel comparing A:B (mesh trial) A:C (graft trial)
35 centres in UK
65 surgeons
Remote Web‐based randomisation
2‐Year follow‐up
Modified ITT analysis
Participants 1352 randomised, 320 randomised within posterior repair subgroup
n = 1348
Mesh trial (overall not just posterior)
A: 111 (430)
B: 111 (435)
Graft trial
A: 93 (367)
C: 98 (368)
35 centres
Primary anterior or posterior repairs
Interventions A: native tissue
B: synthetic mesh
C: biological graft
Outcomes
  • Repeat surgery for prolapse

  • Recurrent posterior vaginal wall prolapse (objective failure)

  • Prolapse outcomes

    • Mean postop Bp, Ba, C

  • QOL (POP‐SS) ‐ this is the primary outcome in this trial

  • Adverse events ‐ postoperative complications

Notes HTA‐funded study in UK
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated online programme
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Patients were blinded until 12 months unless asked
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Reviewers attempted to remain blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk 20% at 2 years.
Specific attrition rates for posterior repair groups not given
Selective reporting (reporting bias) Low risk Reported on all primary outcomes of this review, protocol available
Other bias Low risk Funding declared and no COI
Concomitant procedures included anterior and apical repair procedures ‐ same numbers in comparison groups had concomitant procedures