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Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01470586
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : November 11, 2011
Sponsor:
Collaborator:
University of Ioannina
Information provided by (Responsible Party):
E.Tsimoyiannis, G. Hatzikosta General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Colon Rectal Resection Oxidative Stress Procedure: Surgery for colorectal cancer Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer
Study Start Date : May 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Controls



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT01470586


Locations
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Greece
G. Hatzikosta General Hospital
Ioannina, Epirus, Greece, 45001
Sponsors and Collaborators
G. Hatzikosta General Hospital
University of Ioannina
Investigators
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Principal Investigator: George Pappas-Gogos, MD G. Hatzikosta General Hospital

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Responsible Party: E.Tsimoyiannis, Head of Department of Surgery, G.Hatzikosta General Hospital, G. Hatzikosta General Hospital
ClinicalTrials.gov Identifier: NCT01470586     History of Changes
Other Study ID Numbers: GH-1948-08
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: November 11, 2011
Last Verified: November 2011

Keywords provided by E.Tsimoyiannis, G. Hatzikosta General Hospital:
Colorectal cancer
Surgical resection
Oxidative Stress Markers
Controls

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