Trial Information

Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

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.

PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within 5
years.