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

Phase 3

Not yet recruiting

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

• Registration Number: NCT06936774
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Background: After surgical treatment of patients with rectal cancer, up to 65% experience a symptom complex known as LARS (Low Anterior Resection Syndrome). Those affected suffer from symptoms such as fecal incontinence, frequent bowel movements and a strong urge to defecate, which can severely impair their quality of life. Therapy options include treatment with medication such as bulking agents or drugs that reduce bowel motility, pelvic floor muscle training or stimulation of the nerves that control the function of the rectum and pelvic floor.

Objective: The aim of the present study is to investigate whether an intensified follow-up program can improve the LARS symptoms and consequently the quality of life of patients after rectal resection. If the planned study shows success of the program, we will be able to structurally improve the aftercare of those affected.

Methods: The study is being conducted at several centers in Switzerland, including St. Claraspital Basel. Patients who have had a rectal resection are recruited prior to the repositioning of the artificial bowel outlet, which was created during the primary operation, and randomly assigned to one of the both study groups (intensified follow-up or standard treatment). The symptoms are recorded using various questionnaires and patients will be treated according to our action plan. If LARS symptoms occur, patients receive drug treatment, pelvic floor physiotherapy and, if necessary, sacral neurostimulation, which means implanting a device which stimulates the nerves that control the function of the rectum and pelvic floor. If patients suffer from urinary problems or impaired sexual function they will be referred to our urology or gynecology department for further diagnosis and treatment.

Study Timeline

• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-20
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-02
• Last Update Posted: 2025-07-03
• Study Start: 2025-08-01
• Primary Completion: 2028-05-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• patients older than 18 years
• patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy
• able to give informed consent as documented by signature

Exclusion Criteria

• dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects
• impossibility of stoma reversal due to persistent anastomotic leak and/or local recurrence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement of the LARS score after 13 months	13 months after closure of ileostomy	The primary outcome is the change of the LARS score after participation for 13 months in an intensified follow-up program compared to standard treatment which means patients are only treated if they present themselves in our consultation hours due to complaints. The LARS score is recorded using the LARS score questionnaire, developed 2012 by Emmertson et al.. The LARS score consists of five questions on the topics incontinence for flatus, incontinence for liquid stools, frequency of bowel movements, clustering of stools and urgency. Each answer results in a number of points, those points are summarized in the end to give a total score. This score is categorized into a range of no LARS (score 21 and lower), minor LARS (score 21 - 29) and major LARS (score 30 - 42).

Secondary Outcome Measures

Name	Time	Method
Patients' quality of life (QoL)	1, 4, 7 and 13 months after closure of ileostomy	Patients' quality of life will be recorded using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Colorectal Cancer (EORTC-QLQ-CR29) which will be filled out by the patients before closure of ileostomy as well as 1, 4, 7 and 13 months after closure of ileostomy.; Maximum score is 140 points, minimum score 35 points. Higher scores mean worse outcomes.
Urinary symptoms in women and men	1, 4, 7 and 13 months after closure of ileostomy	Urinary symptoms in women and men will be recorded using the American Urological Association Symptom Index (AUA-SI) which is a validated questionnaire for urinary symptoms in women and men.; Maximum score is 35 points, minimum score 0 points. Higher scores mean worse outcomes.
Sexual function in women	1, 4, 7 and 13 months after closure of ileostomy	Sexual function in women will be recorded using the International Consultation on Incontinence Questionnaire Female Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ-FLUTSsex) which is a validated questionnaire for sexual complaints in women.; Maximum score is 14 points, minimum score 0 points. Higher scores mean worse outcomes.
Sexual function in men	1, 4, 7 and 13 months after closure of ileostomy	Sexual function in men will be recorded using the International Index of Erectile Dysfunction (IIEF-5) which is a validated questionnaire for sexual complaints in men.; Maximum score is 25 points, minimum score 5 points. Higher scores mean better outcomes.
Costs	13 months
Compliance to treatment intervention	13 months	Recording of drop-outs, patients refusing to participate in interventions, tolerance of the medication and recording of side effects.
Readmission to hospital	13 months
Natural history of incidence of LARS symptoms in control group	13 months	Incidence of LARS symptoms will be measured by the LARS score. The LARS score consists of five questions on the topics incontinence for flatus, incontinence for liquid stools, frequency of bowel movements, clustering of stools and urgency. Each answer results in a number of points, those points are summarized in the end to give a total score. This score is categorized into a range of no LARS (score 21 and lower), minor LARS (score 21 - 29) and major LARS (score 30 - 42).
Prevalence of LARS	13 months
Rate of secondary ostomy formation	13 months

Trial Locations

Locations (5)

Clarunis Universitäres Bauchzentrum Basel; 🇨🇭 Basel, Switzerland

Lindenhofspital Bern; 🇨🇭 Bern, Switzerland

St. Anna Spital Bern; 🇨🇭 Bern, Switzerland

Kantonsspital Luzern; 🇨🇭 Luzern, Switzerland

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland