AzTrials
AzTrials

Rectal ProlapseNCT06455501

FOAM: Functional Outcome After Ventral Mesh Rectopexy

An observational study of Rectal Prolapse, run by Uppsala University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Prolapse
What is being tested?
Ventral mesh rectopexy
Type of treatment
Surgery or procedure
How many people
70 participants
Where
No sites listed yet
Study dates
1 Sep 2024to 31 Aug 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jannica Smedberg, MD contact

+46731525453

jannica.smedberg@gotland.se

About this study

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

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.
Read the 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
Being tested
Ventral mesh rectopexy
Keywords
Ventral mesh rectopexy, Laparoscopic ventral mesh rectopexy, Quality of Life, Bowel function, Recurrence, Sexual function
Medical subject headings
Rectal Prolapse, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ventral mesh rectopexyProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel function

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

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

  2. Bowel function

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

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

  3. Bowel function

    Colo-rectal-anal Distress Inventory (CRADI-8): scale 0-100 (100=worst outcome)

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

  4. Quality of Life after surgery

    Colorectal-Anal Impact Questionnaire (CRAIQ-7): scale 0-100, 100=worst outcome

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

  5. 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)

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

Secondary outcomes (5)

  1. Recurrence rate

    Recurrence of rectal prolapse

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

  2. Postoperative complications

    Clavien Dindo classification

    Measured: Within 30 days postoperatively

  3. Long-term complications

    Ileus, pelvic abscess, mesh erosion, other complications

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

  4. Length of stay

    Stay in hospital postoperatively

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

  5. Mortality

    30-day mortality

    Measured: Within 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06455501
Sponsor's protocol ID
FOAM-trial
Status last verified
Jun 2024
First submitted
15 May 2024
Last updated
12 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33863582

  • 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.

    PubMed 8646957

Questions about this trial

What is this clinical trial studying?

An observational study of Rectal Prolapse, run by Uppsala University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jannica Smedberg, MD (+46731525453, jannica.smedberg@gotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel function (time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06455501, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.

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