Sand 2001.
Methods | Prospective, randomised, controlled trial Participant selection by computer‐generated random number tables 12‐Month follow‐up |
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Participants | 161 women enrolled in trial Anterior/posterior colporrhaphy with polyglactin 910 mesh (80) Anterior/posterior colporrhaphy without polyglactin 910 mesh (80) (1 woman excluded) 17 lost to follow‐up at 52 months Inclusion: cystocele protruding to or beyond the hymenal ring in the standing position while coughing or straining, regardless of other concurrent prolapse. Participants had to be > 18 years old, ambulatory, and willing to comply with return visits. Exclusion: pregnant or contemplating pregnancy in the next 12 months. Had only an anterior enterocele or only a paravaginal defect with no need for central cystocele repair at the time of reconstructive surgery Patients seen at 2, 6, 12, and 52 weeks after surgery |
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Interventions | Anterior/posterior colporrhaphy with polyglactin 910 mesh (80) Anterior/posterior colporrhaphy without polyglactin 910 mesh (80) (1 woman excluded) |
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Outcomes |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number tables |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque, sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Examiner not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 17 lost to follow‐up at 52 months (11%). Not stated in study to which groups these were assigned, but it is stated that loss to follow‐up was not significantly different between the 2 groups |
Selective reporting (reporting bias) | Unclear risk | Reported on 1 of this review's primary outcomes, protocol not found |
Other bias | Unclear risk | Not stated Concomitant procedure was anterior vaginal repair; same numbers in both comparison groups had concomitant procedures. |