Methods | Single‐centre RCT CONSORT: no Randomisation: computer generated Allocation concealment: N/S Women, surgeons, and reviewers not blinded 12 months' follow‐up |
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Participants | Inclusion criteria: women who were recommended vaginal surgery for anterior
and posterior compartment with ≥ grade 2 prolapse Exclusion criteria: only requiring anterior or posterior compartment surgery, apical prolapse beyond the hymen, or those requiring abdominal mesh surgery Randomised: 139 (A 70, B 69); 10 women breached study protocol, and 11 more recruited. All were analysed Lost to follow‐up: A 6, B 9 Analysed 12 months: A 63, B 61 |
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Interventions | A (70): traditional anterior and posterior fascial plication using
polydioxanone sutures B (69): anterior and posterior repair with Gynemesh PS augmentation |
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Outcomes | Assessed at 6 months and 1 year postop Reports the following review outcomes at 1 year:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Native tissue 63/70; mesh 63/69 1 year |
Selective reporting (reporting bias) | Low risk | Reports main review outcomes |
Other bias | High risk | Funding not stated: authors' conflict of interest financial agreement with Ethicon manufacturer of product evaluated in study |