Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer.
Katrine J Emmertsen, Søren Laurberg
https://pubmed.ncbi.nlm.nih.gov/22504191Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06936774
Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
Led by University Hospital, Basel, Switzerland · Updated on 2026-05-06
140
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
St. Claraspital AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether an intensified follow-up program can improve symptoms of Low Anterior Resection Syndrome (LARS) and quality of life in patients who have undergone rectal resection for rectal cancer. This study compares patients receiving the intensified follow-up program with those receiving standard care to determine if additional support helps reduce symptoms such as fecal incontinence and frequent bowel movements. The study is a randomized controlled trial conducted at multiple centers in Switzerland and sponsored by the University Hospital Basel. Participants in the intervention group attend follow-up visits at 1, 4, 7, and 13 months after ileostomy repositioning. During these visits, LARS symptoms, quality of life, and urinary and sexual function are assessed through questionnaires. Patients with symptoms receive medical treatments such as loperamide and metamucil, pelvic floor muscle training with biofeedback and home exercises, and if needed, sacral neurostimulation or transanal irrigation. Those with urinary or sexual complaints are referred to urology or gynecology departments for further care. The control group follows standard treatment guidelines with symptom recording at 1 and 13 months. Participants will undergo multiple assessments including questionnaire evaluations of symptoms, quality of life, and sexual and urinary function at various timepoints. Researchers will monitor hospital readmissions, treatment compliance, healthcare costs, and the natural course of LARS symptoms over 13 months. The primary outcome is the improvement in the LARS score after 13 months. The study also tracks secondary outcomes like quality of life and symptom changes at several visits. Participants are involved in medical treatments, physiotherapy, and specialist referrals as needed throughout the study period.
CONDITIONS
Brief Title
Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients with rectal cancer in the middle or lower third of the rectum, stages I to IV
- Patients who underwent low anterior resection with total mesorectal excision and protective ileostomy
- Able to provide informed consent as shown by signature
You will not qualify if you...
- Dementia or psychiatric disorders preventing questionnaire completion or sustained training effects
- Inability to reverse stoma due to persistent anastomotic leak or local cancer recurrence
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 13 months
Participants receive either an intensified follow-up program or standard treatment after ileostomy repositioning. The intensified program includes medical treatment, pelvic floor muscle training, and referral to urology or gynecology departments if needed based on symptoms.
Follow-up visits at 1, 4, 7, and 13 months after ileostomy repositioning
Trial Site Locations
Total: 5 locations
1
Clarunis Universitäres Bauchzentrum Basel
Basel, Switzerland, 4002
Actively Recruiting
2
Lindenhofspital Bern
Bern, Switzerland
Actively Recruiting
3
St. Anna Spital Bern
Bern, Switzerland
Not Yet Recruiting
4
Kantonsspital Luzern
Lucerne, Switzerland
Actively Recruiting
5
Kantonsspital Winterthur
Winterthur, Switzerland
Actively Recruiting
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Research Team
F
Felicitas Wiedemann, Resident
M
Marco von Strauss und Torney, Senior physician
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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