Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)

Recruiting · NCT06914245 · Interventional (participants receive a specific treatment)

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Interventions studied

Electronic bowel diaryEuroQoL 5 dimensions, 5 levels (EQ-5D-5L)Faecal Incontinence Quality of Life questionnaire (FIQL)

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 negatively affects various aspects of bowel function and patients' quality of life. These bowel symptoms often remain prevalent, even 12 months after RC treatment. The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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 is running

1 location listed.

UZ Leuven - Leuven, Vlaams-Brabant, Belgium

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →