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

Colorectal Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00002575
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 3
• Start date: August 1994
• Completion date: November 2009