Prospective Comparison of Immunological Benefit of Laparoscopic Colectomy

August 28, 2008 updated by: Samsung Medical Center

Prospective Comparative Study of Immunological Benefit Between Laparoscopic Colectomy and Open Colectomy

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

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hospital based cohort

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OC
Open colorectal resection
LC
Laparoscopic colorectal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Immune factors
Time Frame: post OP 5th day
post OP 5th day

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-operative complications
Time Frame: POD 7th days
POD 7th days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2008

Last Update Submitted That Met QC Criteria

August 28, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB 2005-08-041
  • #CRS-106-14-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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