NCT06274190Recruiting
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Towards Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients Through Precision Medicine
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 31 Jan 2024
- Start date
- Apr 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- KU Leuven
- Diseases
- Colorectal cancer
- NCT number
- NCT06274190
What you commit to
- Study type: Interventional
- Planned participants: 158
- From Apr 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
Other illness
- Are affected by neurological disorders affecting bowel function.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
Related publications
- Development of S.Tool: An electronic diary for assessing bowel symptoms after rectal cancer surgery.Eur J Surg Oncol · 2026 · PMID 41894921
This page is information, not medical advice. Discuss any trial with your doctor.