Rectal Prolapse
Conditions
Keywords
Ventral mesh rectopexy, Laparoscopic ventral mesh rectopexy, Quality of Life, Bowel function, Recurrence, Sexual function
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.
Interventions
PROCEDUREVentral 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.
Sponsors
Uppsala University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bowel function | Evaluated at baseline, 3-6 months and 12 months postoperatively | Wexner constipation score: scale 0-30, 30=worst outcome |
| Quality of Life after surgery | Evaluated at baseline, 3-6 months and 12 months postoperatively | Colorectal-Anal Impact Questionnaire (CRAIQ-7): scale 0-100, 100=worst outcome |
| Sexual function | Evaluated at baseline, 3-6 months and 12 months postoperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | From day of operation to day of discharge from hospital, reported at follow-up 3-6 months postoperatively. | Stay in hospital postoperatively |
| Recurrence rate | Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. Clinical examination by surgeon will be performed to evaluate recurrence. | Recurrence of rectal prolapse |
| Mortality | Within 30 days postoperatively | 30-day mortality |
| Postoperative complications | Within 30 days postoperatively | Clavien Dindo classification |
| Long-term complications | Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively. | Ileus, pelvic abscess, mesh erosion, other complications |
Contacts
Primary ContactJannica Smedberg, MD
Outcome results
None listed