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Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00744159
First Posted: August 29, 2008
Last Update Posted: August 29, 2008
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.
Information provided by:
Samsung Medical Center
  Purpose
This study aimed to clarify existence of immunological benefit of laparoscopic colon cancer surgery compared to open colon surgery.

Condition
Immunity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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 ]

Secondary Outcome Measures:
  • Post-operative complications [ Time Frame: POD 7th days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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: Woo Yong Lee/Associate Professor, Department of Surgery, Samsung Medical Center, Samsugn Medical Center
ClinicalTrials.gov Identifier: NCT00744159     History of Changes
Other Study ID Numbers: IRB 2005-08-041
#CRS-106-14-1
First Submitted: August 27, 2008
First Posted: August 29, 2008
Last Update Posted: August 29, 2008
Last Verified: August 2008

Keywords provided by Samsung Medical Center:
colon cancer
laparoscopic colorectal surgery
cellular immunity
HLA-DR expression on monocyte