Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485316
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : March 31, 2009
Information provided by:
Chinese University of Hong Kong

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.

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Procedure: Laparoscopic assisted resection of colorectal carcinoma Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Primary Outcome Measures :
  1. Overall survival and disease-free survival

Secondary Outcome Measures :
  1. Operative time
  2. Blood loss
  3. Postoperative analgesic requirements
  4. Recovery of gastrointestinal function (time to resume normal diet, time first passing flatus, time of first bowel motion)
  5. Time to walk independently
  6. Duration of hospital stay
  7. Morbidity and mortality
  8. Direct cost

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00485316

Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Principal Investigator: Ka Lau Leung, MD Chinese University of Hong Kong

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ka Lau Leung, The Chinese University of Hong Kong Identifier: NCT00485316     History of Changes
Other Study ID Numbers: CRE-8118
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases