Park 2014 Abstract.
Methods | Single‐centre RCT Computer‐generated randomisation schedule Patients were blinded to examiner (nurse). Two years' follow‐up Sample size of 50 per group provides 80% power to detect a 20% difference between groups. ITT analysis Groups same at the start Follow‐up 6 weeks, 6 months, 12 months, 24 months Completed 2 years' follow‐up: Gp A 43/53 (77%); Gp B 38/53 (72%) |
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Participants | 172 eligible 109 randomised (63 excluded) Inclusion: women aged 31 to 77 years with symptomatic prolapse (≥ stage 2) undergoing laparoscopic sacral colpopexy Exclusion: none A: 56 B: 53 Completed analysis in 2 years: Gp A 43 (77%); Gp B 38 (72%) |
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Interventions | A: Native tissue repair 56 2. Biological graft 53 |
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Outcomes |
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Notes | t‐tests and regression analyses used to determine statistical significance USA |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block, similar groups |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded for 2 years |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded examiner |
Incomplete outcome data (attrition bias) All outcomes | High risk | At 2 years, native tissue 43/53 (77%) (23% attrition) Biological graft 38/53 (72%) (28% attrition) |
Selective reporting (reporting bias) | High risk | No primary outcomes of this review reported, protocol not found |
Other bias | Unclear risk | Not stated Trial done in women undergoing a different operation ‐ laparoscopic sacral colpopexy |