Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Open colectomy; Procedure: laparoscopic colectomy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• colorectal cancer

Exclusion Criteria:

• metastases
• recurrent disease
• chronic diseases

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach	preoperative, intraoperative, 6h postop, 24h postop

Collaborators and Investigators

• Sponsor: G. Hatzikosta General Hospital
• Collaborators: University of Ioannina

Publications and helpful links

General Publications

• Pappas-Gogos G, Tellis C, Lasithiotakis K, Tselepis AD, Tsimogiannis K, Tsimoyiannis E, Chalkiadakis G, Chrysos E. Oxidative stress markers in laparoscopic versus open colectomy for cancer: a double-blind randomized study. Surg Endosc. 2013 Jul;27(7):2357-65. doi: 10.1007/s00464-013-2788-8. Epub 2013 Feb 13.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 26, 2009
• Last Update Submitted That Met QC Criteria: June 25, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Laparoscopic surgery; Cytokines; Oxidative stress markers; Lipid peroxidation; hsCRP; Open surgery; Protein peroxidation; DNA peroxidation; RNA peroxidation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: GH-1948-03; GHDS-12345-3