Registry for patients undergoing ventral mesh rectopexy for pelvic organ prolapse

Multicenter Ventral Mesh Rectopexy Registry Collaborative

This study is collecting information from patients with pelvic organ prolapse who are having a specific type of surgery to see how well it works and what problems might come up later.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Antwerp (Academic / other)
• Locations: 5 sites (Brussels and 4 other locations)
• Trial ID: NCT05918367 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to collect prospective data on patients with pelvic organ prolapse who are undergoing ventral mesh rectopexy via laparoscopy or robotic surgery. The study will evaluate long-term functional outcomes and complications such as mesh erosions, recurrence, and reoperations. Key questions include the effectiveness of ventral mesh rectopexy for treating rectoceles and the impact of perineal descent on functional outcomes. The registry is based on ongoing research at the University Hospital of Antwerp.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with posterior pelvic organ prolapse who are scheduled for laparoscopic or robotic ventral mesh rectopexy.

Not a fit: Patients who are pregnant, unable to provide informed consent, or have language barriers may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and quality of life for patients suffering from pelvic organ prolapse.

How similar studies have performed: Other studies have shown promising results with similar surgical techniques, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.
* All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.

Exclusion Criteria:

1. Inability to complete a written informed conscent
2. Pregnant women
3. No email adress available to send the questionnaires to
4. Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)

Where this trial is running

Brussels and 4 other locations

• UZ Brussel — Brussels, Belgium (Recruiting)
• University Hospital Antwerp — Edegem, Belgium (Recruiting)
• AZ Jan Palfijn — Ghent, Belgium (Not_yet_recruiting)
• Jessa ziekenhuis — Hasselt, Belgium (Recruiting)
• AZ Delta Roeselare — Roeselare, Belgium (Recruiting)

Study contacts

• Study coordinator: Sylvie Van den Broeck

Conditions Pelvic Organ Prolapse; Rectocele; Enterocele; Rectal Prolapse; Descending Perineum Syndrome; Surgery; Posterior pelvic organ prolapse; descending perineum