Surgical Resection Lowers Oxidative Stress Markers in Patients With Colorectal Cancer

• Sponsor: G. Hatzikosta General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01470586
• Collaborator: University of Ioannina (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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 1, 2009
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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 Controls

Outcome Measures

Primary Outcome Measures

1. Comparison of Oxidative stress markers in patients with colorectal cancer and controls [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 [up to 2 years]

   Validation of the responsiveness of markers of oxidative stress 8-PGF2α, Protein Carboyls, 3-Nitrotyrosine, 8-OHG)on surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	G. Hatzikosta General Hospital	Ioannina	Epirus	Greece	45001

Sponsors and Collaborators

• G. Hatzikosta General Hospital
• University of Ioannina

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: E.Tsimoyiannis, Head of Department of Surgery, G.Hatzikosta General Hospital, G. Hatzikosta General Hospital
• ClinicalTrials.gov Identifier: NCT01470586
• Other Study ID Numbers: GH-1948-08
• First Posted: Nov 11, 2011
• Last Update Posted: Nov 11, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by E.Tsimoyiannis, Head of Department of Surgery, G.Hatzikosta General Hospital, G. Hatzikosta General Hospital: Colorectal cancer; Surgical resection; Oxidative Stress Markers; Controls
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

No Results Posted as of Nov 11, 2011