Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

NCT ID: NCT00744159

Last Updated: 2008-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-11-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Immunity

Keywords

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colon cancer laparoscopic colorectal surgery cellular immunity HLA-DR expression on monocyte

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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OC

Open colorectal resection

No interventions assigned to this group

LC

Laparoscopic colorectal resection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsugn Medical Center

Principal Investigators

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Woo Yong Lee, MD,PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

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Samsung Medical Center, Department of surgery

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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#CRS-106-14-1

Identifier Type: -

Identifier Source: secondary_id

IRB 2005-08-041

Identifier Type: -

Identifier Source: org_study_id