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

Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Cancer; LARS - Low Anterior Resection Syndrome; Rectal Cancer Surgery; Quality of Life (QOL)
• Intervention / Treatment: Other: Intensified follow-up program

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 Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Felicitas Wiedemann, Resident; Phone Number: +41 61 777 76 09; Email: felicitasinga.wiedemann@clarunis.ch
• Study Contact Backup: Name: Marco von Strauss und Torney, Senior physician; Phone Number: +41 61 777 7581; Email: marco.vonstrauss@clarunis.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4002
    • Recruiting
    • Clarunis Universitäres Bauchzentrum Basel
  • Bern, Switzerland
    • Recruiting
    • Lindenhofspital Bern
    • Contact: Dominik Jakob; Phone Number: 0041 31 632 59 00; Email: dominik.jakob@insel.ch
  • Bern, Switzerland
    • Not yet recruiting
    • St. Anna Spital Bern
    • Contact: local PI
  • Lucerne, Switzerland
    • Recruiting
    • Kantonsspital Luzern
    • Contact: Jörn Markus Gass; Phone Number: 041 205 45 39; Email: markus.gass@luks.ch
  • Winterthur, Switzerland
    • Recruiting
    • Kantonsspital Winterthur
    • Contact: Benjamin Weixler; Phone Number: 004152 266 20 40; Email: viszeralchirurgie@ksw.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Intensified follow-up program consisting of of several follow-up visits at 1, 4, 7 and 13 months and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints which will be recorded using questionnaires.	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.
No Intervention: Control group; Treatment according to standard guidelines, recording of symptoms using questionnaires at 1 and 13 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of the LARS score after 13 months	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).	13 months after closure of ileostomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' quality of life (QoL)	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.	1, 4, 7 and 13 months after closure of ileostomy
Urinary symptoms in women and men	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.	1, 4, 7 and 13 months after closure of ileostomy
Sexual function in women	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.	1, 4, 7 and 13 months after closure of ileostomy
Sexual function in men	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.	1, 4, 7 and 13 months after closure of ileostomy
Readmission to hospital		13 months
Costs		13 months
Compliance to treatment intervention	Recording of drop-outs, patients refusing to participate in interventions, tolerance of the medication and recording of side effects.	13 months
Natural history of incidence of LARS symptoms in control group	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).	13 months
Prevalence of LARS		13 months
Rate of secondary ostomy formation		13 months

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: St. Claraspital AG; Clarunis - Universitäres Bauchzentrum Basel
• Investigators: Study Chair: Daniel Steinemann, Deputy chief physician, Clarunis - Universitäres Bauchzentrum Basel

Publications and helpful links

General Publications

• Emmertsen KJ, Laurberg S. Low anterior resection syndrome score: development and validation of a symptom-based scoring system for bowel dysfunction after low anterior resection for rectal cancer. Ann Surg. 2012 May;255(5):922-8. doi: 10.1097/SLA.0b013e31824f1c21.
• Rosen RC, Cappelleri JC, Smith MD, Lipsky J, Pena BM. Development and evaluation of an abridged, 5-item version of the International Index of Erectile Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res. 1999 Dec;11(6):319-26. doi: 10.1038/sj.ijir.3900472.
• Roberts RO, Jacobsen SJ, Jacobson DJ, Reilly WT, Talley NJ, Lieber MM. Natural history of prostatism: high American Urological Association Symptom scores among community-dwelling men and women with urinary incontinence. Urology. 1998 Feb;51(2):213-9. doi: 10.1016/s0090-4295(97)00505-0.

Helpful Links

• Quality of life questionnaire (EORTC-QLQ-CR29 for colorectal cancer)
• ICIQ-FLUTSsex (questionnaire for sexual complaints in women)

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rectal cancer; Rectal resection; Low Anterior Resection Syndrome; Low anterior resection; LARS; Intensified follow-up
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms
• Other Study ID Numbers: iRECOVER_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No