Actively Recruiting

Age: 18Years +
All Genders
ID05918367

Multicenter Ventral Mesh Rectopexy Registry Collaborative for Pelvic Organ Prolapse Evaluation

Led by University Hospital, Antwerp · Updated on 2023-10-25

200

Participants Needed

5

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pelvic organ prolapse (POP), a condition where pelvic organs fall out of their normal place due to weakened support muscles. This study focuses on patients undergoing ventral mesh rectopexy (VMR), a surgery done by laparoscopy or robotic methods to treat various types of posterior pelvic prolapse such as rectocele, enterocele, sigmoidocele, and rectal prolapse. The goal is to understand long-term functional results and complications like mesh erosion, recurrence, and reoperations. The study collects data from multiple centers, following patients who have VMR surgery with or without additional procedures. Data include medical history, symptoms, surgical details, and complications. Patients complete questionnaires before surgery and at 3 months, 1 year, 3 years, and 5 years after surgery. These questionnaires cover pelvic floor function, bowel and urinary symptoms, sexual health, and quality of life. Data are recorded securely using an electronic system to maintain patient anonymity. Participants will be recruited from outpatient surgery clinics and monitored for up to 5 years. Assessments include symptom questionnaires, clinical history, imaging or manometry results if available, and surgical outcomes. Researchers will analyze functional success, impact of perineal descent on results, recurrence rates, and mesh-related issues over time. This long-term follow-up aims to provide detailed understanding of VMR effectiveness and safety in treating pelvic organ prolapse.

CONDITIONS

Brief Title

Multicenter Ventral Mesh Rectopexy Registry Collaborative

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of posterior pelvic organ prolapse planned for laparoscopic or robotic ventral mesh rectopexy with or without additional surgery
  • Age 18 years or older
  • Ability to provide written informed consent
  • Ability to complete written questionnaires
Not Eligible

You will not qualify if you...

  • Unable to provide written informed consent
  • Pregnant women
  • No email address available to receive questionnaires
  • Language barrier or inability to complete questionnaires as judged by treating physician
  • Any other condition preventing participation as determined by physician discretion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay duration

Participants undergo ventral mesh rectopexy surgery for pelvic organ prolapse with follow-up during hospital stay.

1 visit (in-person surgery and immediate post-operative care)

Post-operative Follow-up

Duration - Up to 5 years

Participants complete questionnaires and are monitored for functional outcomes, complications, and quality of life after surgery.

Questionnaires at preoperative, 3 months, 1 year, 3 years, and 5 years postoperative

Trial Site Locations

Total: 5 locations

1

UZ Brussel

Brussels, Belgium

Actively Recruiting

2

University Hospital Antwerp

Edegem, Belgium, 2650

Actively Recruiting

3

AZ Jan Palfijn

Ghent, Belgium

Not Yet Recruiting

4

Jessa ziekenhuis

Hasselt, Belgium

Actively Recruiting

5

AZ Delta Roeselare

Roeselare, Belgium

Actively Recruiting

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Research Team

S

Sylvie Van den Broeck

N

Niels Komen

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

An update of a former FIGO Working Group Report on Management of Posterior Compartment Prolapse.

Stergios K Doumouchtsis, Ali Abdel Raheem, Jorge Milhem Haddad...

https://pubmed.ncbi.nlm.nih.gov/31628853