Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer

OBJECTIVES:

- Compare the disease-free and overall survival rates of patients with colon cancer
treated with laparoscopic-assisted colectomy vs open colectomy.

- Compare the safety of these regimens in terms of early and late morbidity and 30-day
mortality of these patients.

- Compare the differences in costs and cost effectiveness between these treatments in
this patient population.

- Compare the differences in quality of life of patients treated with these regimens.
(closed as of 4/30/99)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and
American Society of Anesthesiologists disease classification (I and II vs III). Patients are
randomized to one of two treatment arms.

The extent of colon resection is identical for both arms.

DISEASE CHARACTERISTICS:

- Clinical diagnosis of primary adenocarcinoma

- Involving a single colon segment:

- Right colon from the ileocecal valve up to and including the hepatic
flexure

- Left colon from the splenic flexure to the junction of the sigmoid and
descending colon

- Sigmoid colon between the descending colon and the rectum (at least 15 cm
from the dentate)

- Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema
or a colonoscopy

- No advanced local disease that renders laparoscopic resection impossible

- No acutely obstructed or perforated colon cancer requiring urgent surgery

- No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic
flexure)

- No stage IV disease

- No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less
than 15 cm from dentate)

- No American Society of Anesthesiologists IV/V disease classification

- No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis,
or familial polyposis) that require additional extensive operative evaluation or
intervention

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Other:

- No other prior or concurrent malignancy within the past 5 years except superficial
squamous cell or basal cell skin cancer or carcinoma in situ of the cervix

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Surgery:

- No prohibitive scars/adhesions from prior abdominal surgery

Other:

- No concurrent investigational treatments or invasive diagnostic procedures within 30
days after surgery