FOAM: Functional Outcome After Ventral Mesh Rectopexy

NCT ID: NCT06455501

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-08-31

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.

Conditions

Rectal Prolapse

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilhelm Graf, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Surgical Sciences, Uppsala Universitet

Central Contacts

Jannica Smedberg, MD

Role: CONTACT

jannica.smedberg@gotland.se

+46731525453

References

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.

Reference Type: BACKGROUND

PMID: 26599079 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15499644 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23384148 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26163960 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25110205 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21306343 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37007849 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33863582 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8646957 (View on PubMed)

Other Identifiers

FOAM-trial

Identifier Type: -

Identifier Source: org_study_id