Randomized Study of Intensified Follow-Up to Improve Symptoms and Quality of Life After Rectal Cancer Surgery

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.

Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance