Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
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|ClinicalTrials.gov Identifier: NCT00485316|
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : March 31, 2009
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Carcinoma||Procedure: Laparoscopic assisted resection of colorectal carcinoma||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma|
|Study Start Date :||September 1993|
|Primary Completion Date :||October 2008|
|Study Completion Date :||October 2008|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485316
|Prince of Wales Hospital|
|Hong Kong SAR, China|
|Principal Investigator:||Ka Lau Leung, MD||Chinese University of Hong Kong|