Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse.
A D'Hoore, R Cadoni, F Penninckx
https://pubmed.ncbi.nlm.nih.gov/15499644/Actively Recruiting
Led by University Hospital, Antwerp · Updated on 2023-10-25
200
Participants Needed
5
Research Sites
104 weeks
Total Duration
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
Multicenter Ventral Mesh Rectopexy Registry Collaborative
S
Sylvie Van den Broeck
N
Niels Komen
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University Hospital, Antwerp
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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https://pubmed.ncbi.nlm.nih.gov/17031741/University Hospital, Antwerp
Lead Sponsor