Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival and disease-free survival
Ka Lau Leung, MD
Principal Investigator
Chinese University of Hong Kong
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
CRE-8118
NCT00485316
September 1993
October 2008
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