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Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance
Sponsor: University Hospital, Basel, Switzerland
Summary
The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.
Official title: Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-08-01
Completion Date
2028-07-01
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
Intensified follow-up program
The study intervention will be an intensified follow-up program which consists of different measures. Patients will attend follow-up visits 1, 4, 7 and 13 months after ileostomy repositioning, at which LARS symptoms, quality of life as well as sexual and urinary function will be recorded using various questionnaires. In case of LARS symptoms patients will receive medical treatment with loperamide and metamucil as well as pelvic floor muscle training (including biofeedback and home exercises). Regarding pelvic floor muscle training we are planning nine sessions instructed by physiotherapy staff. In case of therapy-resistant LARS symptoms after 6 months sacral neurostimulation is offered to the patients with a focus on incontinence symptoms and desire for surgery or transanal irrigation in patients with a focus on voiding disorders. In case of urinary and sexual complaints patients are referred to our urology or gynaecology department for further diagnostic and treatment.
Locations (5)
Clarunis Universitäres Bauchzentrum Basel
Basel, Switzerland
Lindenhofspital Bern
Bern, Switzerland
St. Anna Spital Bern
Bern, Switzerland
Kantonsspital Luzern
Lucerne, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland