An observational study in Rectal Prolapse, sponsored by Uppsala University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by Uppsala University · Observational
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:
Participants will:
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 70 is below the median of 200 across 21 observational studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults undergoing ventral mesh rectopexy for full-thickness rectal prolapse.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Bowel function
Wexner constipation score: scale 0-30, 30=worst outcome
Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Bowel function
Wexner incontinence score: scale 0-20, 20=worst outcome
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Evaluated at baseline, 3-6 months and 12 months postoperatively
Recurrence rate
Recurrence of rectal prolapse
Time frame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence.
Postoperative complications
Clavien Dindo classification
Time frame: Within 30 days postoperatively
Long-term complications
Ileus, pelvic abscess, mesh erosion, other complications
Time frame: Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
Length of stay
Stay in hospital postoperatively
Time frame: From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively.
Mortality
30-day mortality
Time frame: Within 30 days postoperatively
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2024; primary completion for Aug 2026, 23 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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