FOAM: Functional Outcome After Ventral Mesh Rectopexy

June 11, 2024 updated by: Uppsala University

FOAM: Functional Outcome After Ventral Mesh Rectopexy, Prospective Cohort Study

Rectal prolapse is a protrusion of rectal wall through the anus. A surgical technique called Ventral mesh rectopexy has become a standard procedure for this condition in many centers.

The goal of this trial is to investigate functional outcome, recurrence rates and complications after ventral mesh rectopexy. The main question it aims to answer is:

- Do bowel function, quality of life and sexual function improve after Ventral mesh rectopexy?

Participants will:

  • be asked to fill in questionaires before surgery, 3-6 months after surgery and 12 months after surgery.
  • be examined by a surgeon 3-6 months, 12 months and 3 years after surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Several different procedures have been described for surgical treatment of rectal prolapse and a consensus has not yet been reached. Over the past 20 years, the use of Ventral mesh rectopexy to treat external rectal prolapse has gained increasing worldwide acceptance. Ventral mesh rectopexy has become a standard procedure in many centers based on low recurrence rates, limited complications and good functional results but the use and type of mesh have been debated. Concerns have also been expressed regarding the choice of surgical technique, which differs between centers, and the lack of high-level evidence.

There are few prospective trials and the use of LVMR in a Swedish setting has not yet been evaluated. FOAM (Functional Outcome After ventral Mesh rectopexy) therefore aims to investigate bowel function, quality of life, sexual function, recurrence rates and complications after ventral mesh rectopexy.

A prospective cohort study on patients undergoing ventral mesh rectopexy for external rectal prolapse in Sweden will be conducted. Approximately 70 patients will be included at a maximum of 10 hospitals in Sweden.

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults undergoing ventral mesh rectopexy for full-thickness rectal prolapse.

Description

Inclusion Criteria:

  • full-thickness rectal prolapse
  • the surgeon agrees that ventral mesh rectopexy is needed for the condition
  • capable of participating in follow-up visits and answering questionnaires
  • informed consent

Exclusion Criteria:

  • patient below 18 years of age
  • ongoing pregnancy
  • inability to understand the Swedish language
  • dementia or other cognitive disorder that unables informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel function
Time Frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Wexner constipation score: scale 0-30, 30=worst outcome
Evaluated at baseline, 3-6 months and 12 months postoperatively
Bowel function
Time Frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Wexner incontinence score: scale 0-20, 20=worst outcome
Evaluated at baseline, 3-6 months and 12 months postoperatively
Bowel function
Time Frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Colo-rectal-anal Distress Inventory (CRADI-8): scale 0-100 (100=worst outcome)
Evaluated at baseline, 3-6 months and 12 months postoperatively
Quality of Life after surgery
Time Frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Colorectal-Anal Impact Questionnaire (CRAIQ-7): scale 0-100, 100=worst outcome
Evaluated at baseline, 3-6 months and 12 months postoperatively
Sexual function
Time Frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
PROMIS Sexual function and satisfaction version 2.0. Selected domains: Interest in sexual activity (scale 2-10, 10=highest interest), sexual activity screener (scale yes/no) and satisfaction with sex life (scale 2-10, 10=highest satisfaction)
Evaluated at baseline, 3-6 months and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.
Recurrence of rectal prolapse
Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.
Postoperative complications
Time Frame: Within 30 days postoperatively
Clavien Dindo classification
Within 30 days postoperatively
Long-term complications
Time Frame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
Ileus, pelvic abscess, mesh erosion, other complications
Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
Length of stay
Time Frame: From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.
Stay in hospital postoperatively
From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.
Mortality
Time Frame: Within 30 days postoperatively
30-day mortality
Within 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Wilhelm Graf, Professor, Department of Surgical Sciences, Uppsala Universitet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2029

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOAM-trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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