C18
Conditions
Interventions
Group 1: Accomplishment of a decompressing stoma followed by a two-stage oncological elective resection after convalescence
Group 2: Emergency resection of the left-sided obstructive colon
tumor
Sponsors
Technische Universität Dresden
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative 120-day mortality | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Germany
Contacts
Public ContactChristoph Kahlert
Universitätsklinikum Heidelberg
Outcome results
None listed