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NCT Number: NCT06455501

FOAM: Functional Outcome After Ventral Mesh Rectopexy

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.

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Key information

Conditions

Rectal Prolapse Digestive System Diseases Disease Attributes Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventral mesh rectopexy

Procedure

Ventral mesh rectopexy is performed with a superficial peritoneal incision from the right side of the sacral promontory, extended over the right outer border of the mesorectum, towards the deepest part of pouch of Douglas, sparing the right hypogastric nerve. In women, the vagina is retracted anteriorly and a dissection of the rectovaginal septum is performed down to the pelvic floor. A strip of mesh is attached to the ventral part of distal rectum and then fixed upon the sacral promontory.

Primary outcomes

  1. Bowel function

    Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively

    Wexner constipation score: scale 0-30, 30=worst outcome

  2. Bowel function

    Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively

    Wexner incontinence score: scale 0-20, 20=worst outcome

  3. 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)

  4. 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

  5. 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)

Secondary outcomes

  1. 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

  2. Postoperative complications

    Time frame: Within 30 days postoperatively

    Clavien Dindo classification

  3. Long-term complications

    Time frame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.

    Ileus, pelvic abscess, mesh erosion, other complications

  4. 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

  5. Mortality

    Time frame: Within 30 days postoperatively

    30-day mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Jannica Smedberg, MD

CONTACT

[email protected]

+46731525453

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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