NCT06914245 Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)
| NCT ID | NCT06914245 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-04-28 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-04-28 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection combined with chemoradiotherapy. However, this treatment negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment. The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.
Eligibility Criteria
Inclusion Criteria: * Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures. * At least 18 years of age at the time of signing the Informed Consent Form (ICF). * Proficient in reading, comprehending, and conversing in Dutch. * Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer. Exclusion Criteria: * The participant has undergone a different type of surgery, including a Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection. * Experienced fecal incontinence prior to undergoing surgery. * Are affected by neurological disorders affecting bowel function. * Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons. * Has a permanent stoma.
Contact & Investigator
Inge Geraerts, PhD
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT06914245 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06914245 currently recruiting?
Yes, NCT06914245 is actively recruiting participants. Contact the research team at inge.geraerts@kuleuven.be for enrollment information.
Where is the NCT06914245 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06914245 clinical trial?
NCT06914245 is sponsored by KU Leuven. The principal investigator is Inge Geraerts, PhD at KU Leuven. The trial plans to enroll 150 participants.
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