deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer
- Conditions
- C18Malignant neoplasm of colon
- Registration Number
- DRKS00031827
- Lead Sponsor
- Technische Universität Dresden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 468
Colonic obstruction of patients with a left-sided colon or upper rectal tumor (splenic flexure to the intraperitoneal rectum (tumor > 12 cm from the anal verge)) treated with curative intent
- the tumor must be highly suspicious for colon cancer in CT or endoscopy
- proof of colonic dilatation by computed tomography
- the tumor including potential metastases must be deemed curatively resectable
- Capacity of the patient to consent
- Right-sided colon
- Extraperitoneal rectal cancer of the lower and middle third (tumor < 12 cm from the anal verge)
- life expectancy < 120 days due to advanced tumour disease
- locally advanced tumor disease with local infiltration of other structures which excludes a R0 resection or requires a neoadjuvant treatment
- patients treated in palliative intent
- signs of bowel perforation on CT
- patients not eligible for surgery (ASA Score = IV)
- lack of compliance
- Addiction or other illnesses which do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perioperative 120-day mortality
- Secondary Outcome Measures
Name Time Method Patient reported quality of life (EORTC QLQ-C30), Primary anastomosis, 90-day complication rate, Permanent stoma rate after 1 year, comparison of number of resected lymph nodes, comparison of local R0 resection, 3-year overall survival, 3-year cancer-specific survival, 3-year disease-free survival, incisional hernia at 3-years, adjuvant therapy after resection and oncological re-interventions (due to recurrence), quality-adjusted survival (QALY)