Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Study Overview
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Brief Summary
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The aim of the investigators' randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colorectal carcinoma.

Detailed Description
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Since the introduction of laparoscopic cholecystectomy in 1987, laparoscopic surgery has been attempted and applied to many surgical operations. Surgeons in Hong Kong began to perform laparoscopic surgery for colorectal carcinoma in early 1992. Early reports of laparoscopic surgery for colorectal carcinoma from Hong Kong and worldwide suggested better short-term clinical outcomes when compared with open surgery, but there were concerns over port site metastases and adequacy of long-term oncological clearance. Besides, only a few randomized trials thus far have compared laparoscopic-assisted and open surgery for rectal carcinoma. The aim of our randomized trial is to compare the short-term clinical outcome and survival between laparoscopic-assisted and open resection of colonic and rectal carcinoma. Patients will undergo different types of surgery according to the location of the tumors: right or extended right hemicolectomy for cecal, ascending colon, or hepatic flexure tumors; left hemicolectomy for descending colon tumors; sigmoid colectomy for sigmoid colon tumors; anterior resection for rectosigmoid or upper rectal tumors; low anterior resection with total mesorectal excision for mid- and low rectal tumors; abdominoperineal resection for very low rectal tumors. Patients will be randomly allocated to laparoscopic assisted or conventional open surgery. Short-term clinical outcome and long-term survival data will be prospectively recorded and compared between the two treatment arms.

Official Title
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Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma

Conditions
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Colorectal Carcinoma

Intervention / Treatment
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* Procedure: Laparoscopic assisted resection of colorectal carcinoma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed to have colorectal carcinoma at all locations except transverse colon Informed consent available Exclusion Criteria: Patients with tumor >6 cm in size, or with tumor infiltration to adjacent organs on imagings Patients with previous abdominal surgery near the region of the colorectal surgery Patients with intestinal obstruction or perforation Patients with recurrent disease Patients with synchronous colorectal carcinoma
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laparoscopic assisted resection of colorectal carcinoma|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival and disease-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  |  | 
| Blood loss |  |  | 
| Postoperative analgesic requirements |  |  | 
| Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion) |  |  | 
| Time to walk independently |  |  | 
| Duration of hospital stay |  |  | 
| Morbidity and mortality |  |  | 
| Direct cost |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal carcinoma, Rectal carcinoma, Laparoscopy, Laparoscopic surgery, Open surgery, Randomized trial