NORDIC Rectal Prolapse Study
Research type
Research Study
Full title
The NORDIC Rectal Prolapse Study
IRAS ID
325797
Contact name
Julie Cornish
Contact email
Sponsor organisation
Aarhus University
Clinicaltrials.gov Identifier
NCT05569980, ClinicalTrials.gov ID
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
Rectal prolapse is a condition in which the rectum exits through the anus. It is a debilitating condition that can only be treated surgically. To date, more than 100 surgical procedures have been described to treat rectal prolapse. Over the past decades, the approach has become more and more geared towards minimally invasive surgery, where one of the procedures involves attaching a mesh to the front of the patient's rectum, which is attached to the pelvic bone.
There are many indications that this method has many advantages over other methods. However, there is only limited research in the area, most of which have focused on recurrence of the disease. We have therefore assessed that there is a need for a large international study in which the patients' quality of life and bowel function must be included in addition to surgical information.The overall aim of this project is to collect data on rectal prolapse surgeries. In the long term, data will help support the choice of type of surgery, both for surgeons but also for patients. The primary objective is therefore to assess whether endoscopic surgery with attachment of a mesh to the front of the patient's rectum and attachment to the pelvic bone is a better method of treatment of rectal prolapse compared to other surgeries for rectal prolapse. As secondary objectives of the study, we will investigate the effect of the different types of surgery on constipation and quality of life, to investigate the risks of the operations in the short term, to investigate the relationship between the different types of surgery and patient characteristics, and to investigate the risk of recurrence for the different surgical methods.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
25/PR/0048
Date of REC Opinion
20 Mar 2025
REC opinion
Favourable Opinion