Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06274190

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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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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