NCT00003354

Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer

Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Laparoscopic-assisted surgery is a less invasive type of surgery for colorectal cancer and may have fewer side effects and improve recovery. It is not yet known if undergoing conventional surgery is more effective than laparoscopic-assisted surgery for colorectal cancer. PURPOSE: This randomized phase III trial is studying conventional surgery to see how well it works compared to laparoscopic-assisted surgery in treating patients with colorectal cancer.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery
PROCEDURE	laparoscopic surgery

Timeline

• Start date: 1996-07-01
• Completion: 2009-12-01
• First posted: 2003-01-27
• Last updated: 2013-12-04

Locations

13 sites across 1 country: United Kingdom