COLOR II: Laparoscopic Versus Open Rectal Cancer Removal
- Conditions
- Rectal Cancer
- Registration Number
- NCT00297791
- Lead Sponsor
- Nova Scotia Health Authority
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1044
Inclusion Criteria:<br><br> - solitary rectal cancer observed at colonoscopy or on barium X-ray<br><br> - no evidence of distant metastases<br><br> - distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or<br> under linea conjugata at lateral barium enema radiography<br><br> - suitable for elective surgical resection<br><br> - informed consent<br><br>Exclusion Criteria:<br><br> - T1 tumors treated by locl excision<br><br> - T4 tumors<br><br> - patients under 18 years of age<br><br> - signs of acute intestinal obstruction<br><br> - more than one colorectal tumor<br><br> - Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer<br><br> - active crohn's or active ulcerative colitis<br><br> - scheduled need for other synchronous colon surgery<br><br> - preoperative indication of invasion of adjacent organs, immobile at palpation or CT<br> showing invasion<br><br> - preoperative evidence of metastases (at least chest X-ray and liver ultrasound)<br><br> - other malignancies in medical history except adequately treated basocellular<br> carcinoma of the skin or in situ carcinoma of the cervix uteri<br><br> - absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA<br> class > III)<br><br> - pregnancy
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method locoregional recurrence rate
- Secondary Outcome Measures
Name Time Method survival free of cancer recurrence;overall survival;port-site and wound-site recurrences;distant metastases rate;operative mortality and morbidity;macroscopic evaluation of the resected specimen;duration of in-hospital stay;duration of absence of work;postoperative health related quality of life,including standardized questionnaires on sexual and bladder function;in-hospital direct and indirect costs;out-of-hospital postoperative costs