Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
Primary Purpose
Colorectal Carcinoma
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Laparoscopic assisted resection of colorectal carcinoma
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring Colorectal carcinoma, Rectal carcinoma, Laparoscopy, Laparoscopic surgery, Open surgery, Randomized trial
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Outcomes
Primary Outcome Measures
Overall survival and disease-free survival
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00485316
First Posted
June 11, 2007
Last Updated
March 30, 2009
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00485316
Brief Title
Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
Official Title
Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 1993 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
Colorectal carcinoma, Rectal carcinoma, Laparoscopy, Laparoscopic surgery, Open surgery, Randomized trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic assisted resection of colorectal carcinoma
Primary Outcome Measure Information:
Title
Overall survival and disease-free survival
Secondary Outcome Measure Information:
Title
Operative time
Title
Blood loss
Title
Postoperative analgesic requirements
Title
Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
Title
Time to walk independently
Title
Duration of hospital stay
Title
Morbidity and mortality
Title
Direct cost
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ka Lau Leung, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong SAR
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24013470
Citation
Ng SS, Lee JF, Yiu RY, Li JC, Hon SS, Mak TW, Ngo DK, Leung WW, Leung KL. Laparoscopic-assisted versus open total mesorectal excision with anal sphincter preservation for mid and low rectal cancer: a prospective, randomized trial. Surg Endosc. 2014 Jan;28(1):297-306. doi: 10.1007/s00464-013-3187-x. Epub 2013 Sep 7.
Results Reference
derived
PubMed Identifier
21861071
Citation
Li JC, Leung KL, Ng SS, Liu SY, Lee JF, Hon SS. Laparoscopic-assisted versus open resection of right-sided colonic cancer--a prospective randomized controlled trial. Int J Colorectal Dis. 2012 Jan;27(1):95-102. doi: 10.1007/s00384-011-1294-5. Epub 2011 Aug 23.
Results Reference
derived
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Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
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