Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

November 10, 2011 updated by: E.Tsimoyiannis, G. Hatzikosta General Hospital
Study of Oxidative stress Markers (F2 Isoprostanes for lipid peroxidation, Carbonyl groups for protein peroxidation, 3 Nitrotyrosine for damage by nitrogens, and 8-Hydroxyguanosine for RNA peroxidation)in patients with colorectal cancer undergo surgical treatment (preoperatively during the intervention and postoperatively) and controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study of the impact of surgery on Lipid peroxidation, Protein peroxidation, damage by nitrogens, and RNA peroxidation, in patients undergo surgical resection for colorectal cancer and compared with controls, and validation of the responsiveness of oxidative stress markers on surgery

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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

  • Greece
    • Epirus
      • Ioannina, Epirus, Greece, 45001
        • G. Hatzikosta General Hospital

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

25 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with colorectal cancer
  • Controls

Exclusion Criteria:

  • ASA>3
  • Metastatic Disease
  • Acute bowel obstruction
  • Acute bowel perforation
  • BMI<30
  • Chronic Systemic or Autoimmune Diseases
  • Smokers
  • Alcohol consumers

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

  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery for colorectal cancer
Colorectal cancer patients
Procedure: Surgery for colorectal cancer
Surgical resection of colorectal cancer
Other Names:
  • Open or Laparoscopic resection for colorectal cancer
  • Low anterior resection
  • Sigmoidectomy
  • Left colectomy
  • Trasverse colectomy
  • Right colectomy
No Intervention: Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Oxidative stress markers in patients with colorectal cancer and controls
Time Frame: up to 2 years
Oxidative stress markers variation (8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG) during and after surgery for colorectal cancer, and compare with controls
up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of oxidative stress markers in patients with colorectal cancer undergo surgical resection
Time Frame: up to 2 years
Validation of the responsiveness of markers of oxidative stress 8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery
up to 2 years

Collaborators and Investigators

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

Sponsor

G. Hatzikosta General Hospital

Collaborators

University of Ioannina

Investigators

  • Principal Investigator: George Pappas-Gogos, MD, G. Hatzikosta General Hospital

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

May 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

November 5, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

November 11, 2011

Last Update Submitted That Met QC Criteria

November 10, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH-1948-08

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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