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 |
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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 |
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Interventions | A: native tissue B: synthetic mesh C: biological graft |
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Outcomes |
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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 |