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Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Ioannina
Information provided by:
G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier:
NCT00928928
First received: June 25, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer


Condition Intervention Phase
Colorectal Cancer
 Procedure: Open colectomy
Procedure: laparoscopic 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: Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach [ Time Frame: preoperative, intraoperative, 6h postop, 24h postop ]

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • colorectal cancer

Exclusion Criteria:

  • metastases
  • recurrent disease
  • chronic diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00928928

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

No publications provided

Responsible Party: George Pappas-Gogos,MD, G Hatzikosta General Hospital, Ioannina, Greece
ClinicalTrials.gov Identifier: NCT00928928     History of Changes
Other Study ID Numbers: GH-1948-03, GHDS-12345-3
Study First Received: June 25, 2009
Last Updated: June 25, 2009
Health Authority: Greece: Ethics Committee

Keywords provided by G. Hatzikosta General Hospital:
Lipid peroxidation
Protein peroxidation
DNA peroxidation
RNA peroxidation
Cytokines
 hsCRP
Oxidative stress markers
Open surgery
Laparoscopic surgery

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 16, 2013