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Sponsored by: |
Chinese University of Hong Kong |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00485316 |
Although laparoscopic resection of colorectal carcinoma improves postoperative recovery, long-term survival and disease control are the determining factors for its application. The aim of our randomized trial is to test the null hypothesis that there is no difference in survival after laparoscopic assisted and open resection for colorectal carcinoma.
Condition | Intervention | Phase |
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Colorectal Carcinoma |
Procedure: Laparoscopic assisted resection of colorectal carcinoma |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colorectal Carcinoma |
Study Start Date: | September 1993 |
Estimated Study Completion Date: | June 2007 |
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 to open surgery, but there were concerns over port site metastases and adequacy of oncological clearance.
The aim of our randomized trial is to test the null hypothesis that there is no difference in survival after laparoscopic assisted and open resection for colorectal 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 outcomes and long-term survival data will be prospectively recorded and compared between the two treatment arms.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Simon SM Ng, FRCSEd (Gen) | +852-26321495 | simonng@surgery.cuhk.edu.hk |
Contact: Ka Lau Leung, MD | +852-26323932 | leungkl@msn.com |
China | |
Prince of Wales Hospital | Recruiting |
Hong Kong SAR, China | |
Sub-Investigator: Simon SM Ng, FRCSEd (Gen) |
Principal Investigator: | Ka Lau Leung, MD | Chinese University of Hong Kong |
Study ID Numbers: | CRE-8118 |
Study First Received: | June 11, 2007 |
Last Updated: | June 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00485316 |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Colorectal carcinoma Rectal carcinoma Laparoscopy |
Laparoscopic surgery Open surgery Randomized trial |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases |
Rectal cancer Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |