Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With 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.

DISEASE CHARACTERISTICS:

• Histologically confirmed colorectal cancer
• Must be suitable for elective surgical resection by right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection or abdomino-perineal resection
• No adenocarcinoma of the transverse colon
• No synchronous multiple adenocarcinomas

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Pulmonary:

• No contraindication to pneumoperitoneum such as severe cardio-respiratory disease

Other:

• No acute intestinal obstruction
• No prior malignancy within the past 5 years, except basal cell carcinoma, carcinoma in situ of the cervix, or prostate cancer
• Not pregnant
• No gastrointestinal disease that requires surgical intervention, e.g., Crohn's disease, chronic ulcerative disease, familial polyposis

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified
• Adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• Preoperative radiotherapy must be administered before randomization into this trial
• Adjuvant radiotherapy allowed

Surgery:

• See Disease Characteristics