Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Switzerland
Clarunis Universitäres Bauchzentrum Basel
RECRUITING
Basel
Lindenhofspital Bern
RECRUITING
Bern
St. Anna Spital Bern
NOT_YET_RECRUITING
Bern
Kantonsspital Luzern
RECRUITING
Lucerne
Kantonsspital Winterthur
RECRUITING
Winterthur
Contact Information
Primary
Felicitas Wiedemann, Resident
felicitasinga.wiedemann@clarunis.ch
+41 61 777 76 09
Backup
Marco von Strauss und Torney, Senior physician
marco.vonstrauss@clarunis.ch
+41 61 777 7581
Time Frame
Start Date:2025-12-01
Estimated Completion Date:2028-07-01
Participants
Target number of participants:140
Treatments
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.
No_intervention: Control group
Treatment according to standard guidelines, recording of symptoms using questionnaires at 1 and 13 months.