Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy - Full Text View

Purpose

This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Condition

Immunity

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Immune factors [ Time Frame: post OP 5th day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-operative complications [ Time Frame: POD 7th days ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	84
Study Start Date:	January 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts

OC

Open colorectal resection

LC

Laparoscopic colorectal resection

Detailed Description:

Patients with clinical stage Ⅲ left colon and upper rectal cancer were prospectively assigned to undergo LC (n=35) or OC (n=39). Factors related to cellular immunity of host (total lymphocyte count, CD4 lymphocyte, CD8 lymphocyte, CD4/CD8 ratio, HLA-DR expression on monocyte (mHLA-DR)) were examined preoperatively, on the 1st day of operation (POD1) and the 5th day of operation (POD5).

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

hospital based cohort

Criteria

Inclusion Criteria:

Biopsy proven of colon cancer
Preoperatively suspected as clinical stage III colon cancer
Lesion located Descending colon, sigmoid colon and upper rectal cancer

Exclusion Criteria:

Could not perform curative resection
Intestinal obstruction, perforation, intra-abdominal abscess
Severe medical illness
Immunopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00744159

Locations


Korea, Republic of
	Samsung Medical Center, Department of surgery
	Seoul, Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators


Study Chair:	Woo Yong Lee, MD,PhD	Samsung Medical Center

More Information

Responsible Party:	Samsugn Medical Center ( Woo Yong Lee/Associate Professor, Department of Surgery, Samsung Medical Center )
Study ID Numbers:	IRB 2005-08-041, #CRS-106-14-1
First Received:	August 27, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00744159
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

colon cancer

laparoscopic colorectal surgery

cellular immunity

HLA-DR expression on monocyte

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00744159