Actively Recruiting
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Led by KU Leuven · Updated on 2026-04-15
158
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent given before screening
- At least 18 years old when signing informed consent
- Able to read, understand, and speak Dutch
- Patients who had rectal surgery for rectal cancer or are under Watch and Wait (active surveillance) protocol
You will not qualify if you...
- Had other types of surgery such as Hartmann procedure, abdominoperineal excision, transanal endoscopic microsurgery, or sigmoid resection
- Had fecal incontinence before surgery
- Have neurological disorders affecting bowel function
- Previously received pelvic radiation or rectal surgery for non-cancer reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
I
Inge Geraerts, PhD
CONTACT
L
Liesbet Lauwereins, MSc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
6
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