Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT00003354|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: conventional surgery Procedure: laparoscopic surgery||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Official Title:||Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer|
|Study Start Date :||July 1996|
|Study Completion Date :||December 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003354
|Bucks, England, United Kingdom, MK6 5LR|
|Castle Hill Hospital|
|Cottingham, England, United Kingdom, HU16 5JQ|
|Leeds General Infirmary at Leeds Teaching Hospital NHS Trust|
|Leeds, England, United Kingdom, LS1 3EX|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Liverpool and Broadgreen Hospitals|
|Liverpool, England, United Kingdom, L7 8XP|
|Imperial College School of Medicine at St. Mary's|
|London, England, United Kingdom, W2 1PG|
|Newcastle Upon Tyne Hospitals NHS Trust|
|Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Salford Royal Hospitals NHS Trust|
|Salford, England, United Kingdom, M6 8HD|
|Airedale General Hospital|
|West Yorkshire, England, United Kingdom, BD20 6TD|
|Ninewells Hospital and Medical School|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Royal Infirmary of Edinburgh at Little France|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|University Hospital of Wales|
|Cardiff, Wales, United Kingdom, CF14 4XN|
|Study Chair:||P.J. Guillou, MD||Leeds Cancer Centre at St. James's University Hospital|