Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
- Conditions
- Colorectal Cancer
- Registration Number
- NCT00003354
- Lead Sponsor
- Medical Research Council
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Saxon Clinic
🇬🇧Bucks, England, United Kingdom
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust
🇬🇧Leeds, England, United Kingdom
Newcastle Upon Tyne Hospitals NHS Trust
🇬🇧Newcastle-Upon-Tyne, England, United Kingdom
Royal Liverpool and Broadgreen Hospitals
🇬🇧Liverpool, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Queen's Medical Centre
🇬🇧Nottingham, England, United Kingdom
Imperial College School of Medicine at St. Mary's
🇬🇧London, England, United Kingdom
Salford Royal Hospitals NHS Trust
🇬🇧Salford, England, United Kingdom
Airedale General Hospital
🇬🇧West Yorkshire, England, United Kingdom
Royal Infirmary of Edinburgh at Little France
🇬🇧Edinburgh, Scotland, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom