NCT06274190 Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
| NCT ID | NCT06274190 |
| Status | Recruiting |
| Phase | — |
| Sponsor | KU Leuven |
| Condition | Rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 158 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2026-07 |
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 158 participants in total. It began in 2024-04-29 with a primary completion date of 2026-07.
⚠ 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 will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, the study population was expanded to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.
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 after rectal surgery for rectal cancer or under Watch and Wait protocol (also referred to as active surveillance). 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.
Contact & Investigator
Inge Geraerts, PhD
PRINCIPAL INVESTIGATOR
KU Leuven
Frequently Asked Questions
Who can join the NCT06274190 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 NCT06274190 currently recruiting?
Yes, NCT06274190 is actively recruiting participants. Contact the research team at inge.geraerts@kuleuven.be for enrollment information.
Where is the NCT06274190 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT06274190 clinical trial?
NCT06274190 is sponsored by KU Leuven. The principal investigator is Inge Geraerts, PhD at KU Leuven. The trial plans to enroll 158 participants.
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