Sung 2012

Methods	2‐centre, double‐blinded randomised control trial Allocation concealment: sealed envelopes Randomisation block and stratified site Women and assessors blinded (women unblinded 12 months) Based on a study by Kohli et al (Kohli 2003) assuming that graft use is associated with a 93% anatomic success rate, 63 women per group would be needed to detect a 20% difference at .05 and .20. We aimed to recruit 160 women (80 women per group) to account for drop‐out
Participants	Inclusion criteria: women with stage 2 or greater symptomatic rectocele (defined as vaginal bulge, defecatory symptoms, or both) electing surgical repair were eligible Exclusion criteria: < 18 years, women undergoing concomitant sacrocolpopexy or colorectal procedures, history of porcine allergy, connective tissue disease, pelvic malignancy, pelvic radiation, inability to understand English, or unable or unwilling to consent or comply with follow‐up. All other vaginal prolapse repairs and anti‐incontinence procedures were included
Interventions	Gp A: 70 controls midline plication or site‐specific repair Gp B: 67 midline plication or site‐specific repair with 4 x 7 cm subintestinal submucosal graft over the repair and secured to levator ani fascia using interrupted No. 2‐0 polyglycolic acid and inferiorly to the perineal body using No. 2‐0 polyglycolic acid sutures. Excess vaginal tissue was trimmed in all women, and the posterior vaginal incision was closed using 2‐0 polyglycolic acid sutures. The deep and superficial transverse perineal muscles and bulbocavernosus muscles were re‐approximated using No. 0 polyglycolic acid sutures, and concomitant perineorrhaphy was performed in all women
Outcomes	Assessed at 6 months and 1 year Reports the following outcomes at median 12.2 to 12.5 months (range 10 to 43 months): Awareness of prolapse (vaginal bulge) Recurrent prolapse (objective failure of posterior vaginal wall) Bladder injury 0 vs 1 Rectal injury 1 vs 0 Objective failure of posterior vaginal wall (POPQ stage 2 or more) Ap or pt Bp POPQ assessment of prolapse at pt Bp (reports median and range) Bowel function assessed with Pelvic Distress Index defecatory function questions
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence
Allocation concealment (selection bias)	Low risk	Sealed, opaque envelopes
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinded reviewers
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	1 year Gp A 70/80, Gp B 67/79
Selective reporting (reporting bias)	Low risk	Reports main review outcomes
Other bias	Low risk	No financial COI; grant funding National Institute of Child and Human Health