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NCT00744159 Clinical Trial

Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

Immunity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00744159
Other study ID # IRB 2005-08-041
Secondary ID #CRS-106-14-1
Status Completed
Phase N/A
First received August 27, 2008
Last updated August 28, 2008
Start date January 2006
Est. completion date November 2007

Study information
Verified date August 2008
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Department of surgery Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immune factors post OP 5th day No
Secondary Post-operative complications POD 7th days Yes
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