colorectal cancer rectal neoplasm
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: *1. > 18 years old 2. Patients with primary rectal cancer without distant metastases who underwent CRT and show clinical complete response or very good response : 2A. Clinical complete response (ycT0N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI) 2B. Very good response (ycT1-2N0) after neo-adjuvant chemoradiation will be determined clinically (digital rectal examination, endoscopy) and radiologically (contrast-enhanced-MRI). These patients will undergo a TEM to resect the small residual tumor 3. Comprehension of the alternative strategies and the concept of unknown risks are clear to the patient 4. Choosing for the organ-saving treatment option (wait&see policy or TEM) 5. Informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to understand or read Dutch 2. Unwilling to comply to the questionnaires or manometric measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Functional outcome scores of patients that are treated with an organ saving strategy compared to patients who undergo the standard resection as described in literature. Functional outcome will be evaluated with questionnaires (quality of life). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Cumulative risk of local failure within 5 years * Cumulative risks of disease-free, distant-metastasis free and overall survival within 5 years * The percentage of patients that choose the alternative strategies instead of traditional strategies and the motivation for their choice * The compliance to the intensive follow-up schedule * Early detection of local failure (standard surgery still possible) | — |
Countries
Netherlands
Outcome results
None listed