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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Conventional Versus Laparoscopic-Assisted Surgery in Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed colorectal cancer Must be suitable for elective surgical resection by right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection or abdomino-perineal resection No adenocarcinoma of the transverse colon No synchronous multiple adenocarcinomas PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No contraindication to pneumoperitoneum such as severe cardio-respiratory disease Other: No acute intestinal obstruction No prior malignancy within the past 5 years, except basal cell carcinoma, carcinoma in situ of the cervix, or prostate cancer Not pregnant No gastrointestinal disease that requires surgical intervention, e.g., Crohn's disease, chronic ulcerative disease, familial polyposis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Adjuvant chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: Preoperative radiotherapy must be administered before randomization into this trial Adjuvant radiotherapy allowed Surgery: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Procedure: laparoscopic surgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I colon cancer, stage II colon cancer, stage III colon cancer, stage IV colon cancer, stage 0 colon cancer, stage 0 rectal cancer, stage I rectal cancer, stage II rectal cancer, stage III rectal cancer, stage IV rectal cancer