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

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%)
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%)
Interventions A: Native tissue repair 56
2. Biological graft 53
Outcomes
  • Adverse events

    • Mesh exposure

Notes t‐tests and regression analyses used to determine statistical significance
USA
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