Clinical trial NCT06936774: Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance
Official title: Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: St. Claraspital AG
name: Clarunis - Universitäres Bauchzentrum Basel
First posted: 2025-04-20
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement of the LARS score after 13 months
timeFrame: 13 months after closure of ileostomy
Secondary outcomes:
measure: Patients' quality of life (QoL)
timeFrame: 1, 4, 7 and 13 months after closure of ileostomy
measure: Urinary symptoms in women and men
timeFrame: 1, 4, 7 and 13 months after closure of ileostomy
measure: Sexual function in women
timeFrame: 1, 4, 7 and 13 months after closure of ileostomy
measure: Sexual function in men
timeFrame: 1, 4, 7 and 13 months after closure of ileostomy
measure: Readmission to hospital
timeFrame: 13 months
measure: Costs
timeFrame: 13 months
measure: Compliance to treatment intervention
timeFrame: 13 months
measure: Natural history of incidence of LARS symptoms in control group
timeFrame: 13 months
measure: Prevalence of LARS
timeFrame: 13 months
measure: Rate of secondary ostomy formation
timeFrame: 13 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Clarunis Universitäres Bauchzentrum Basel
city: Bern
country: Switzerland
facility: Lindenhofspital Bern
city: Bern
country: Switzerland
facility: St. Anna Spital Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Daniel Steinemann, Deputy chief physician
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.