Cytokine Changes After Colorectal Cancer Resection

July 15, 2013 updated by: Drazen Servis, University Hospital Dubrava

Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer

Based on our previous research, this study aims to determine reliable surgical stress response markers in patients undergoing radical resection of colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Every surgical intervention represents a stress for patient's organism. During the operation, numerous changes in the patient's metabolism take place, that are termed surgical stress response. Leading cause of surgical stress response is tissue destruction that always accompanies operations. Surgical stress response is effected through activation of hypothalamus-pituitary-adrenal axis and through sympathetic activation.

The consequences of surgical stress response are numerous. Surgical stress response is essential to uneventful postoperative recovery. On the other hand, excessive surgical stress response may lead to serious postoperative complications, such as heart and kidney failure, venous thrombosis, disruption of operative wound and wound infection.

In prior studies the investigators have shown the kinetics of postoperative serum interleukin changes after radical resection of gastric cancer.

This study aims at determining reliable markers of surgical stress response severity in patients undergoing radical resection of colorectal cancer.

Study Type

Observational

Enrollment (Actual)

28

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

  • Croatia
      • Zagreb, Croatia, 10000
        • University Hospital Dubrava

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with colorectal cancer treated in the University Hospital Dubrava

Description

Inclusion Criteria:

  • Pathohistologically verified colorectal cancer

Exclusion Criteria:

  • Distant metastases noticed before or during surgery
  • History of autoimmune diseases or immunodeficiencies
  • Use of immunomodulatory drugs within 1 year prior to surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal cancer patients
Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia
Procedure: colorectal cancer resection
Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
Other Names:
  • Hemicolectomy
  • Rectosigmoid resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative changes of serum cytokine levels
Time Frame: 1 day, 2 days and 7 days postoperatively
Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.
1 day, 2 days and 7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Early postoperative complications
Time Frame: Within one month after surgery
Within one month after surgery

Collaborators and Investigators

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

Sponsor

University Hospital Dubrava

Investigators

  • Principal Investigator: Drazen Servis, M.D., Ph.D., University Hospital Dubrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 12, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-P03112010

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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