A PHASE III PROSPECTIVE RANDOMIZED TRIAL COMPARING LAPAROSCOPIC-ASSISTED COLECTOMY VERSUS OPEN COLECTOMY FOR COLON CANCER

Date de début de l'étude : 1 août 1994

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