Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00744159
First received: August 27, 2008
Last updated: August 28, 2008
Last verified: August 2008
  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 ] [ Designated as safety issue: No ]

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

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
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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

No publications provided

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
Study First Received: August 27, 2008
Last Updated: August 28, 2008
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 September 18, 2014