Methods | RCT (computer‐generated random number tables. Sealed envelopes concealed assignment) comparing 3 surgical techniques 3 arms, 1 centre Length of follow‐up: A + B + C, 23.3 months | |
Participants | 83 women Inclusion: all women undergoing cystocele repair Exclusion: continence surgery, i.e. colposuspension or sling 114 randomised 5 withdrawals 26 lost to follow‐up (A 2: B 15: C 9), leaving 83 in trial | |
Interventions | Gp A (33): anterior repair: midline plication without tension 0
PDS Gp B (24): ultra‐lateral: dissection to pubic rami
laterally, plication paravaginal with tension 0 PDS
interrupted Gp C (26): anterior repair plus mesh: standard
plication midline polyglactin (Vicryl) mesh overlay, Vicryl sutures Number and level of surgeons unknown |
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Outcomes | Assessed at 6 months, 1 year, and 2 years Reports the following review outcomes at median follow‐up 23 months (range 4.5 to 44.4 months)
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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) | Low risk | Adequate |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | High risk | 83/114 randomised women included in analysis (73%) |
Selective reporting (reporting bias) | Unclear risk | Main review outcomes reported, but no comparative data for most outcomes |
Other bias | Unclear risk | No statement about funding. Significant disparity between total numbers in Table 7 and actual numbers with prolapse reported |