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Not yet recruiting NCT06455501

FOAM: Functional Outcome After Ventral Mesh Rectopexy

— Observational Rectal Prolapse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ventral mesh rectopexy.
Who it may be relevant to
Registry conditions: Rectal Prolapse. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Procedure Ventral mesh rectopexy
    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 outcome measures

  • Bowel function [Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively]
  • Bowel function [Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively]
  • Bowel function [Time frame: 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]
  • Sexual function [Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively]
Secondary outcome measures (5)
  • 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.]
  • Postoperative complications [Time frame: Within 30 days postoperatively]
  • Long-term complications [Time frame: 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.]
  • Mortality [Time frame: Within 30 days postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Tou S, Brown SR, Nelson RL. Surgery for complete (full-thickness) rectal prolapse in adults. Cochrane Database Syst Rev. 2015 Nov 24;2015(11):CD001758. doi: 10.1002/14651858.CD001758.pub3. PMID 26599079
  • D'Hoore A, Cadoni R, Penninckx F. Long-term outcome of laparoscopic ventral rectopexy for total rectal prolapse. Br J Surg. 2004 Nov;91(11):1500-5. doi: 10.1002/bjs.4779. PMID 15499644
  • Badrek-Al Amoudi AH, Greenslade GL, Dixon AR. How to deal with complications after laparoscopic ventral mesh rectopexy: lessons learnt from a tertiary referral centre. Colorectal Dis. 2013 Jun;15(6):707-12. doi: 10.1111/codi.12164. PMID 23384148
  • Evans C, Stevenson AR, Sileri P, Mercer-Jones MA, Dixon AR, Cunningham C, Jones OM, Lindsey I. A Multicenter Collaboration to Assess the Safety of Laparoscopic Ventral Rectopexy. Dis Colon Rectum. 2015 Aug;58(8):799-807. doi: 10.1097/DCR.0000000000000402. PMID 26163960
  • Randall J, Smyth E, McCarthy K, Dixon AR. Outcome of laparoscopic ventral mesh rectopexy for external rectal prolapse. Colorectal Dis. 2014 Nov;16(11):914-9. doi: 10.1111/codi.12741. PMID 25110205
  • Teleman P, Stenzelius K, Iorizzo L, Jakobsson U. Validation of the Swedish short forms of the Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI-20) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Acta Obstet Gynecol Scand. 2011 May;90(5):483-7. doi: 10.1111/j.1600-0412.2011.01085.x. PMID 21306343
  • Hoven E, Flynn KE, Weinfurt KP, Eriksson LE, Wettergren L. Psychometric evaluation of the Swedish version of the PROMIS Sexual Function and Satisfaction Measures in clinical and nonclinical young adult populations. Sex Med. 2023 Jan 12;11(1):qfac006. doi: 10.1093/sexmed/qfac006. eCollection 2023 Feb. PMID 37007849
  • Wexner SD. Further validation of the Wexner Incontinence Score: A note of appreciation and gratitude. Surgery. 2021 Jul;170(1):53-54. doi: 10.1016/j.surg.2021.02.039. Epub 2021 Apr 15. No abstract available. PMID 33863582

Identifiers

NCT: NCT06455501 · FOAM-trial

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗