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

Paraiso 2006.

Methods Single‐centre RCT (computer‐generated randomisation by sealed envelopes with blinded research nurse)
 106 randomised to:
Posterior colporrhaphy (37)
Site‐specific repair (37)
Site‐specific repair augmented with porcine small intestine submucosa (32: Fortagen, Organogenesis)
June 2002‐December 2004
ITT analysis
93% follow‐up with mean 17.5 months
Assessed at 6 weeks, 6 months, 1 and 2 years
Participants 106 women
 Inclusion: 21 years and over, stage 2 or greater posterior vaginal wall prolapse with or without other prolapse or incontinence or gynaecological procedures
 Exclusion: concomitant colorectal procedures, allergy to pork
Interventions A (37): posterior colporrhaphy as per Maher 2‐0 Ethibond
 B (37): site‐specific repair Cundiff 2‐0 Ethibond
 C (32): as in B with 4x8 cm porcine small intestine submucosa graft inlay (Fortagen)
Outcomes

  • Awareness of prolapse (subjective failure)

  • Repeat surgery for prolapse

  • Recurrent posterior vaginal wall prolapse (objective failure)

  • Bowel symptoms

    • Postoperative obstructed defecation

  • Sexual function

    • Postoperative dyspareunia

  • QOL (PFDI‐20, PFIQ‐7, PISQ‐12)

  • Adverse events

    • Intraoperative complications

    • Postoperative complications

  • Perioperative outcomes

    • Operating time

    • Blood transfusion
Notes Ongoing study: initial full‐text review after 1 year
 ITT basis
 CONSORT statement
 Independent nurse review
 Limited sample size
USA
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated
Allocation concealment (selection bias) Low risk Sequentially numbered, opaque, sealed envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinded up to 6 weeks
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded non‐surgeon reviewer
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At 17.5 months, 33/37 (11% attrition) native tissue, 37/37 (0% attrition) site‐specific, 29/32 biological graft (10% attrition)
Selective reporting (reporting bias) Unclear risk Reported on all of review's primary outcomes, protocol not found
Other bias Unclear risk Declared unrestricted research grant from Organogenesis, whose product was being evaluated. Company had no involvement in designing or running trial.
No concomitant procedures