NCT00744159

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
Last Updated

August 29, 2008

Status Verified

August 1, 2008

Enrollment Period

1.8 years

First QC Date

August 27, 2008

Last Update Submit

August 28, 2008

Conditions

Immunity

Keywords

colon cancerlaparoscopic colorectal surgerycellular immunityHLA-DR expression on monocyte

Outcome Measures

Primary Outcomes (1)

  • Immune factors

    post OP 5th day

Secondary Outcomes (1)

  • Post-operative complications

    POD 7th days

Study Arms (2)

OC

Open colorectal resection

LC

Laparoscopic colorectal resection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

hospital based cohort

You may qualify if:

  • Biopsy proven of colon cancer
  • Preoperatively suspected as clinical stage III colon cancer
  • Lesion located Descending colon, sigmoid colon and upper rectal cancer

You may not qualify if:

  • Could not perform curative resection
  • Intestinal obstruction, perforation, intra-abdominal abscess
  • Severe medical illness
  • Immunopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Department of surgery

Seoul, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Woo Yong Lee, MD,PhD

    Samsung Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 29, 2008

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 29, 2008

Record last verified: 2008-08

Locations

KR(1)