Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary
Recruiting · NCT06274190 · Interventional (participants receive a specific treatment) · Lead sponsor: KU Leuven
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed.
- UZ Leuven - Leuven, Vlaams-Brabant, Belgium