FOAM: Functional Outcome After Ventral Mesh Rectopexy

NCT06455501 | Not Yet Recruiting

• 1 other identifier: FOAM-trial
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rectal Prolapse

Keywords

Ventral mesh rectopexy; Laparoscopic ventral mesh rectopexy; Quality of Life; Bowel function; Recurrence; Sexual function

Outcome Measures

Primary Outcomes (5)

• Bowel function

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

  Evaluated at baseline, 3-6 months and 12 months postoperatively

• Bowel function

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

  Evaluated at baseline, 3-6 months and 12 months postoperatively

• 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

• 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

• 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 Outcomes (5)

• Recurrence rate

  Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.

• Postoperative complications

  Within 30 days postoperatively

• Long-term complications

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

• Length of stay

  From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.

• Mortality

  Within 30 days postoperatively

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing ventral mesh rectopexy for full-thickness rectal prolapse.

You may qualify if:

• 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

You may not qualify if:

• patient below 18 years of age
• ongoing pregnancy
• inability to understand the Swedish language
• dementia or other cognitive disorder that unables informed consent

Sponsors & Collaborators

• Uppsala University: lead

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 8646957 BACKGROUND

MeSH Terms

Conditions

Rectal Prolapse; Recurrence

Condition Hierarchy (Ancestors)

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

Study Officials

• Wilhelm Graf, Professor

  Department of Surgical Sciences, Uppsala Universitet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannica Smedberg, MD

CONTACT

+46731525453; jannica.smedberg@gotland.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: June 12, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share