FOAM: Functional Outcome After Ventral Mesh Rectopexy

Rectal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455501
• Other study ID #: FOAM-trial
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: August 31, 2029

Study information

• Verified date: June 2024
• Source: Uppsala University
• Contact: Jannica Smedberg, MD
• Phone: +46731525453
• Email: jannica.smedberg[@]gotland.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 31, 2029
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bowel function	Wexner constipation score: scale 0-30, 30=worst outcome	Evaluated at baseline, 3-6 months and 12 months postoperatively
Primary	Bowel function	Wexner incontinence score: scale 0-20, 20=worst outcome	Evaluated at baseline, 3-6 months and 12 months postoperatively
Primary	Bowel function	Colo-rectal-anal Distress Inventory (CRADI-8): scale 0-100 (100=worst outcome)	Evaluated at baseline, 3-6 months and 12 months postoperatively
Primary	Quality of Life after surgery	Colorectal-Anal Impact Questionnaire (CRAIQ-7): scale 0-100, 100=worst outcome	Evaluated at baseline, 3-6 months and 12 months postoperatively
Primary	Sexual function	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	Recurrence rate	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.
Secondary	Postoperative complications	Clavien Dindo classification	Within 30 days postoperatively
Secondary	Long-term complications	Ileus, pelvic abscess, mesh erosion, other complications	Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
Secondary	Length of stay	Stay in hospital postoperatively	From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.
Secondary	Mortality	30-day mortality	Within 30 days postoperatively