Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003354
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Conventional Surgery Compared With Laparoscopic-Assisted Surgery in Treating Patients With Colorectal Cancer
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 1200 patients will be accrued for this study within 5 years
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 1200 patients will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN74883561 | None | None | None |
| MRC-CLASICC | None | None | None |
| NYCTRU-CLASICC | None | None | None |
| EU-98014 | None | None | None |