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Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, June 2007
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00485316
  Purpose

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
Colorectal Carcinoma
Procedure: Laparoscopic assisted resection of colorectal carcinoma
Phase III

U.S. FDA Resources
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

Further study details as provided by Chinese University of Hong Kong:

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

Study Start Date: September 1993
Estimated Study Completion Date: June 2007
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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485316

Contacts
Contact: Simon SM Ng, FRCSEd (Gen) +852-26321495 simonng@surgery.cuhk.edu.hk
Contact: Ka Lau Leung, MD +852-26323932 leungkl@msn.com

Locations
China
Prince of Wales Hospital Recruiting
Hong Kong SAR, China
Sub-Investigator: Simon SM Ng, FRCSEd (Gen)            
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Ka Lau Leung, MD Chinese University of Hong Kong
  More Information

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

Keywords provided by Chinese University of Hong Kong:
Colorectal carcinoma
Rectal carcinoma
Laparoscopy
Laparoscopic surgery
Open surgery
Randomized trial

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009