Health TrialsbyHealthPanel

FOAM: Functional Outcome After Ventral Mesh Rectopexy

ConditionRectal Prolapse
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUppsala University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

patient below 18 years of age

ongoing pregnancy

inability to understand the Swedish language

dementia or other cognitive disorder that unables informed consent

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ventral mesh rectopexy

    Procedure/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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Bowel function

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

Time frame
Evaluated at baseline, 3-6 months and 12 months postoperatively
2

Bowel function

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

Time frame
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)

Time frame
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

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

Secondary outcomes

1

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.
2

Postoperative complications

Clavien Dindo classification

Time frame
Within 30 days postoperatively
3

Long-term complications

Ileus, pelvic abscess, mesh erosion, other complications

Time frame
Evaluated at baseline, 3-6 months, 12 months and 3 years postoperatively.
4

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: