Nguyen 2008.
Methods | Single‐centre RCT on anterior vaginal prolapse CONSORT statement: yes Power calculation: 38 in each arm Type of randomisation: computer generated Blinding strategy: primary surgeon ‐ until the surgery day; patients, research nurse and medical assistant remained blinded Allocation concealment: sealed opaque envelopes Definition of cure
Follow‐up: 12 months (full publication) and 24 months (abstract only) Prolapse assessment: POPQ |
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Participants | Inclusion: 21 years old and older with POPQ stage 2 or greater anterior prolapse requiring surgical correction Exclusion: pregnancy (present or contemplated), prior repair with graft, systemic infection, compromised immune system, uncontrolled diabetes mellitus, previous pelvic irradiation/cancer, polypropylene allergy, scheduled for concomitant Burch or pubovaginal sling Randomised: 76 Withdrawal: 1 Lost to follow‐up: 1 Analysed: 76 |
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Interventions | A (38): anterior colporrhaphy (AC) with delayed absorbable (PDS) sutures B (38): AC + polypropylene 4‐armed mesh kit repair (Perigee, American Medical Systems) Concomitant surgery: vaginal hysterectomy, bilateral salpingo‐oophorectomy, uterosacral suspension, mid‐urethral tape, site‐specific rectocele repair, perineoplasty, Apogee mesh kit repair Concomitant prolapse and suburethral tape surgeries were performed in both groups |
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Outcomes | Assessed at 1 year Reported the following review outcomes at 1 year
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Notes | Data regarding study methods were obtained from the full published article, with follow‐up at 12 months PFDI ‐ Pelvic Floor Distress Inventory (quality of life measure) PFIQ ‐ Pelvic Floor Incontinence Questionnaire (quality of life measure) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Low risk | Sealed opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors blinded; participant‐completed questionnaires |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data set complete: AC 37/38, mesh 37/38 |
Selective reporting (reporting bias) | Low risk | Significant outcome data |
Other bias | Unclear risk | No statement |