Clinical trial NCT06455501: FOAM: Functional Outcome After Ventral Mesh Rectopexy
Official title: FOAM: Functional Outcome After Ventral Mesh Rectopexy, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rectal Prolapse
Keywords: Ventral mesh rectopexy
Laparoscopic ventral mesh rectopexy
Quality of Life
Bowel function
Recurrence
Sexual function
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing ventral mesh rectopexy for full-thickness rectal prolapse.

Brief summary: 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.

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

Primary outcomes:
measure: Bowel function
timeFrame: Evaluated at baseline, 3-6 months and 12 months postoperatively
measure: Bowel function
timeFrame: Evaluated at baseline, 3-6 months and 12 months postoperatively
measure: Bowel function
timeFrame: Evaluated at baseline, 3-6 months and 12 months postoperatively
measure: Quality of Life after surgery
timeFrame: Evaluated at baseline, 3-6 months and 12 months postoperatively
measure: Sexual function
timeFrame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Secondary outcomes:
measure: Recurrence rate
timeFrame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.
measure: Postoperative complications
timeFrame: Within 30 days postoperatively
measure: Long-term complications
timeFrame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
measure: Length of stay
timeFrame: From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.
measure: Mortality
timeFrame: Within 30 days postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgical Sciences, Uppsala Universitet
name: Wilhelm Graf, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: Agachan F, Chen T, Pfeifer J, Reissman P, Wexner SD. A constipation scoring system to simplify evaluation and management of constipated patients. Dis Colon Rectum. 1996 Jun;39(6):681-5. doi: 10.1007/BF02056950.