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

NCT06936774 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

  • LARS - Low Anterior Resection Syndrome
  • Rectal Cancer Surgery
  • Rectal Cancer
  • Quality of Life (QOL)

Interventions

OTHER

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.

Sponsors & Collaborators

  • St. Claraspital AG

    collaborator OTHER

  • Clarunis - Universitäres Bauchzentrum Basel

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Daniel Steinemann, Deputy chief physician · Clarunis - Universitäres Bauchzentrum Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-05-01
Completion
2028-07-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936774 on ClinicalTrials.gov