Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Recruiting now · Not applicable

Conditions studied: Rectal Cancer, LARS - Low Anterior Resection Syndrome

In brief

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.

Key facts

Study ID

NCT06274190

Run by

KU Leuven

People needed

158

Starts

2024-04-29

Expected to finish

2026-07-01

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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