Official Title: “Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2008
Detailed Clinical Trial Description
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.
Interventions Used in this Clinical Trial
- Procedure: Laparoscopic assisted resection of colorectal carcinoma
Outcome Measures for this Clinical Trial
- Overall survival and disease-free survival
- 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
Criteria for Participation in this Clinical Trial
- Patients diagnosed to have colorectal carcinoma at all locations except transverse colon
- Informed consent available
- 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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- Chinese University of Hong Kong
- Provider of Information About this Clinical Study
- Ka Lau Leung, The Chinese University of Hong Kong
- Overall Official(s)
- Ka Lau Leung, MD, Principal Investigator, Chinese University of Hong Kong