Status:
COMPLETED
COLOR II: Laparoscopic Versus Open Rectal Cancer Removal
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operati...
Detailed Description
The design involves allocation of all suitable consecutive patients with rectal carcinoma to either of the two procedures at a randomization ratio of 2:1 in favor of the laparoscopic procedure. Exclud...
Eligibility Criteria
Inclusion
- solitary rectal cancer observed at colonoscopy or on barium X-ray
- no evidence of distant metastases
- distal border of the tumor within 15 cm of the anal verge at rigid rectoscopy or under linea conjugata at lateral barium enema radiography
- suitable for elective surgical resection
- informed consent
Exclusion
- T1 tumors treated by locl excision
- T4 tumors
- patients under 18 years of age
- signs of acute intestinal obstruction
- more than one colorectal tumor
- Familial Adenomatosis Polyposis, Hereditary Non-Polyposis Colorectal Cancer
- active crohn's or active ulcerative colitis
- scheduled need for other synchronous colon surgery
- preoperative indication of invasion of adjacent organs, immobile at palpation or CT showing invasion
- preoperative evidence of metastases (at least chest X-ray and liver ultrasound)
- other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- absolute contraindications to general anesthesia or prolonged pneumoperitoneum (ASA class \> III)
- pregnancy
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
1044 Patients enrolled
Trial Details
Trial ID
NCT00297791
Start Date
June 1 2004
End Date
September 1 2015
Last Update
August 21 2024
Active Locations (35)
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1
Universitair Ziekenjuis Leuven
Leuven, Belgium
2
Royal Alexandra Hospital, University of Alberta
Edmonton, Alberta, Canada
3
CDHA/ Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
4
University of Western Ontario
London, Ontario, Canada