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

Sand 2001.

Methods Prospective, randomised, controlled trial
Participant selection by computer‐generated random number tables
12‐Month follow‐up
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
Interventions Anterior/posterior colporrhaphy with polyglactin 910 mesh (80)
Anterior/posterior colporrhaphy without polyglactin 910 mesh (80)
(1 woman excluded)
Outcomes
  • Recurrent posterior vaginal wall prolapse (objective failure)

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.