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Inflammatory Response in Laparoscopic and Open Colectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942461
First Posted: July 21, 2009
Last Update Posted: July 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital
  Purpose
This study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery

Condition Intervention Phase
Colorectal Cancer Procedure: Laparoscopic colectomy Procedure: Open colectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

Further study details as provided by G. Hatzikosta General Hospital:

Primary Outcome Measures:
  • Inflammatory reaction of the patients organism in laparoscopic vs open colorectal surgery for cancer [ Time Frame: preoperative, intraoperative, 6h postop, 24h postop ]

Enrollment: 40
Study Start Date: October 2008
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic Surgery group
Group of patients that are operated with laparoscopic approach
Procedure: Laparoscopic colectomy
Laparoscopic colectomy. Epidural anaesthesia used
Active Comparator: Open surgery Group
Group of patients operated with open approach
Procedure: Open colectomy
Open colectomy. Epidural anaesthesia used

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • colorectal cancer

Exclusion Criteria:

  • metastases
  • stage 4 colorectal cancer
  • recurrent disease
  • chronic diseases
  • obvious inflammatory condition
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942461


Locations
Greece
G Hatzikosta General Hospital
Ioannina, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
University of Ioannina
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Konstantinos E. Tsimogiannis, MD, G. Hatzikosta General Hospital, Ioannina, Greece
ClinicalTrials.gov Identifier: NCT00942461     History of Changes
Other Study ID Numbers: GH-1948-04
GHDS-12345-4
First Submitted: July 20, 2009
First Posted: July 21, 2009
Last Update Posted: July 21, 2009
Last Verified: July 2009

Keywords provided by G. Hatzikosta General Hospital:
a-defensins
TLRs
Inflammatory Cytokines
CRP
No metastases
No other obvious inflammation
No chronic diseases

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases