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 |
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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 |
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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 |
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Outcomes | Assessed at 1 year Reports the following review outcomes:
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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 |
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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 |