Intensified follow-up to reduce bowel symptoms and improve life after rectal cancer surgery
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)
Run by University Hospital, Basel, Switzerland · NCT06936774 · Data updated 2026-11-12
We will test whether an intensified follow-up program can reduce LARS symptoms and improve quality of life for people who have had rectal cancer surgery with a protective ileostomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 5 sites (Basel and 4 other locations) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | May 1, 2028 |
| Study ends | July 1, 2028 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT06936774 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with middle- or lower-third rectal cancer who underwent low anterior resection with total mesorectal excision and a protective ileostomy and who can give informed consent are the intended participants.
✕Probably not a fit
Patients who cannot undergo stoma reversal because of persistent anastomotic leak or local recurrence, or those with dementia or severe psychiatric disorders preventing participation, are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 3 trial enrolls patients after low anterior resection with a protective ileostomy and assigns them to either an intensified follow-up program or standard care. The intensified program includes scheduled follow-up visits, medical treatments (such as bulking agents and motility-reducing drugs), pelvic floor physiotherapy, and gynecological/urological co-treatment when needed, with sacral neurostimulation offered if appropriate. Symptoms and quality of life are measured using validated questionnaires before and after ileostomy reversal and at planned intervals. Outcomes in symptom scores and quality-of-life measures will be compared between groups across multiple centers in Switzerland.
Why it matters
Potential benefit: If successful, the program could reduce bowel dysfunction and improve daily functioning and overall quality of life after rectal resection.
How similar studies have gone: Individual components like pelvic floor therapy, medications, and sacral nerve stimulation have shown benefit for bowel dysfunction, but a combined intensified follow-up pathway has not yet been conclusively proven in randomized Phase 3 trials.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Clarunis Universitäres Bauchzentrum Basel
Basel, Switzerland Recruiting -
Lindenhofspital Bern
Bern, Switzerland Recruiting -
Kantonsspital Luzern
Lucerne, Switzerland Recruiting -
Kantonsspital Winterthur
Winterthur, Switzerland Recruiting -
St. Anna Spital Bern
Bern, Switzerland Not yet recruiting
Study contacts
- Study coordinator: Felicitas Wiedemann, Resident
- Email: felicitasinga.wiedemann@clarunis.ch
- Phone: +41 61 777 76 09
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.