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Clinical Trials/NCT00003354
NCT00003354CompletedPhase 3

Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

Medical Research Council26 sites in 1 country1,200 target enrollmentStarted: July 1996Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
1,200
Locations
26

Study Overview

Brief Summary

RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer.

PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.

Detailed Description

OBJECTIVES:

  • Determine whether longitudinal and circumferential resection margins and lymphatic clearances obtained during laparoscopic surgery are different from those obtained with conventional open surgery in patients with colorectal cancer.
  • Compare the patterns of loco-regional or distant metastatic spread after these two surgical methods in these patients.
  • Compare the morbidity and mortality rates in these patients after these two surgical methods, particularly in terms of the technical or thromboembolic complications that may develop as a consequence of prolonged pneumoperitoneum.
  • Compare the disease-free or overall survival of these patients after these two operative procedures.
  • Determine, in those patients in whom laparoscopic surgery fails, which investigatory modalities are appropriate for providing pre-operative indications that a patient is an inappropriate candidate for laparoscopic dissection.
  • Compare the differences in quality of life between the two operative procedures, particularly in patients with advanced disease.

OUTLINE: This is a randomized, multicenter study.

Patients undergo laparoscopic surgery or conventional open surgery.

Patients are followed at 1 and 3 months following surgery, then every 3 months for the first year, every 4 months for the second year, and then every 6 months thereafter.

Study Design

Study Type
Interventional
Allocation
Randomized
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other Gov

Study Sites (26)

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