Personalized care pathways for bowel symptoms after rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults treated for rectal cancer with total or partial mesorectal excision or managed with a watch-and-wait approach. Participants use an electronic bowel diary and complete standardized questionnaires (FIQL and EQ-5D-5L), with outcomes measured 12 months after surgery or stoma closure, or 12 months after completion of neoadjuvant therapy for surveillance patients. The study links symptom patterns and questionnaire scores to clinical and treatment factors to identify contributors to persistent bowel dysfunction. Results are intended to inform when and which evaluations and treatments should be offered as part of a personalized care pathway.

Why it matters

Who can join: the full rules

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 scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.

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.
* Has a permanent stoma.

Where it's running

• UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Inge Geraerts, PhD — KU Leuven
• Study coordinator: Inge Geraerts, PhD
• Email: inge.geraerts@kuleuven.be
• Phone: +3216329120

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.