Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

This study has been completed.

Sponsor:

Information provided by:

Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT00485316

First received: June 11, 2007

Last updated: March 30, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2007

Last Updated Date

March 30, 2009

Start Date ^ICMJE

September 1993

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Overall survival and disease-free survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00485316 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Laparoscopic Assisted Versus Open Resection for Colorectal Carcinoma

Official Title ^ICMJE

Prospective Randomized Trial Comparing Laparoscopic Assisted and Open Resection for Colonic and Rectal Carcinoma

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Colorectal Carcinoma

Intervention ^ICMJE

Procedure: Laparoscopic assisted resection of colorectal carcinoma

Study Arm (s)

Not Provided

Publications *

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. Epub 2011 Aug 23.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

October 2008

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT00485316

Other Study ID Numbers ^ICMJE

CRE-8118

Has Data Monitoring Committee

Yes

Responsible Party

Ka Lau Leung, The Chinese University of Hong Kong

Study Sponsor ^ICMJE

Chinese University of Hong Kong

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ka Lau Leung, MD

Chinese University of Hong Kong

Information Provided By

Chinese University of Hong Kong

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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