Clinical Trial

Multicenter Ventral Mesh Rectopexy Registry Collaborative

Study acronym: M2R2
Recruiting
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Summary
The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes. Secondly complications (mesh erosions, recurrence, reoperations) are evaluated. Following main questions will be analysed - other can follow in consultation with the collaborative 1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications 2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-15.
Status change: Not Yet Recruiting → Recruiting 2023-10-23
Trial Details
NCT Number NCT05918367
Lead Sponsor University Hospital, Antwerp
Conditions Pelvic Organ Prolapse, Rectocele, Enterocele, Rectal Prolapse, Descending Perineum Syndrome, Surgery
Enrollment 200 participants
Start Date 2023-09-25
Primary Completion 2030-09-30 (estimated)
Study Completion 2032-09-30 (estimated)
Updated on ClinicalTrials.gov 2023-10-25