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Inflammatory Response in Laparoscopic and Open Colectomy

This study has been completed.
Sponsor:
Collaborator:
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT00942461
First received: July 20, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Contribution to the Study of Inflammatory Response in Laparoscopic vs Open Colon Cancer Surgery

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • colorectal cancer

Exclusion Criteria:

  • metastases
  • stage 4 colorectal cancer
  • recurrent disease
  • chronic diseases
  • obvious inflammatory condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942461

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

No publications provided by G. Hatzikosta General Hospital

Additional 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
Study First Received: July 20, 2009
Last Updated: July 20, 2009
Health Authority: Greece: Ethics Committee

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

ClinicalTrials.gov processed this record on May 19, 2013