Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Carcinoma |
Procedure: Laparoscopic assisted resection of colorectal carcinoma |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma |
- 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
| Study Start Date: | September 1993 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided by Chinese University of Hong Kong
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ka Lau Leung, The Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00485316 History of Changes |
| Other Study ID Numbers: | CRE-8118 |
| Study First Received: | June 11, 2007 |
| Last Updated: | March 30, 2009 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
Colorectal carcinoma Rectal carcinoma Laparoscopy |
Laparoscopic surgery Open surgery Randomized trial |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013