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

NCT06936774 | Recruiting Phase 3

• 1 other identifier: iRECOVER_2025
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Keywords

LARS; Low Anterior Resection Syndrome; Intensified follow-up; Rectal cancer; Rectal resection; Low anterior resection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Patients' quality of life (QoL)

  1, 4, 7 and 13 months after closure of ileostomy

• Urinary symptoms in women and men

  1, 4, 7 and 13 months after closure of ileostomy

• Sexual function in women

  1, 4, 7 and 13 months after closure of ileostomy

• Sexual function in men

  1, 4, 7 and 13 months after closure of ileostomy

• Readmission to hospital

  13 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Treatment according to standard guidelines, recording of symptoms using questionnaires at 1 and 13 months.

Interventions

Intensified follow-up program OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• St. Claraspital AG: collaborator
• Clarunis - Universitäres Bauchzentrum Basel: collaborator

Study Sites (5)

Clarunis Universitäres Bauchzentrum Basel

Basel, 4002, Switzerland

RECRUITING

Lindenhofspital Bern

Bern, Switzerland

RECRUITING

St. Anna Spital Bern

Bern, Switzerland

NOT YET RECRUITING

Kantonsspital Luzern

Lucerne, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, Switzerland

RECRUITING

Related Publications (3)

• 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.

  PMID: 22504191 BACKGROUND

• 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.

  PMID: 9495700 BACKGROUND

• 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.

  PMID: 10637462 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Daniel Steinemann, Deputy chief physician

  Clarunis - Universitäres Bauchzentrum Basel

  STUDY CHAIR

Central Study Contacts

Felicitas Wiedemann, Resident

CONTACT

+41 61 777 76 09; felicitasinga.wiedemann@clarunis.ch

Marco von Strauss und Torney, Senior physician

CONTACT

+41 61 777 7581; marco.vonstrauss@clarunis.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group: Intensified follow-up program consisting of 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 which will be recorded using questionnaires. Control group: Treatment according to standard, recording of symptoms using questionnaires only at beginning and end of the study period.

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 20, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CH (5)