Status:
UNKNOWN
COlon Cancer Laparoscopic or Open Resection
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Ethicon Endo-Surgery
Conditions:
Colonic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data wi...
Detailed Description
The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to part...
Eligibility Criteria
Inclusion
- Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
- Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
- Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
- Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
- BMI \< 30 kg/m2
- Informed consent according to local requirements
Exclusion
- Carcinoma of the splenic flexure
- Carcinoma of the transverse colon
- Signs of acute intestinal obstruction
- More than one colon tumour
- Scheduled need for other synchronous colon surgery
- Synchronous surgery ofr other intra-abdominal organs
- Pre-operative indication of invasion of adjacent organs
- Pre-operative evidence of distant metastases
- Previous ipsilateral colon surgery
- Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
- Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
- Pregnancy
Key Trial Info
Start Date :
March 1 1997
Trial Type :
INTERVENTIONAL
End Date :
March 1 2008
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00387842
Start Date
March 1 1997
End Date
March 1 2008
Last Update
October 13 2006
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