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Cytokine Changes After Colorectal Cancer Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01244022
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : July 16, 2013
Information provided by (Responsible Party):
Drazen Servis, University Hospital Dubrava

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

Condition or disease Intervention/treatment
Colorectal Cancer Procedure: colorectal cancer resection

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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
Study Start Date : August 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Early postoperative complications [ Time Frame: Within one month after surgery ]

Biospecimen Retention:   Samples Without DNA
For each patient, serum samples will be stored at -80°C for later determining of serum cytokine levels

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with colorectal cancer treated in the University Hospital Dubrava

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

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 identifier (NCT number): NCT01244022

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University Hospital Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava
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Principal Investigator: Drazen Servis, M.D., Ph.D. University Hospital Dubrava

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Drazen Servis, M.D., Ph. D., University Hospital Dubrava Identifier: NCT01244022    
Other Study ID Numbers: DS-P03112010
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: July 2013
Keywords provided by Drazen Servis, University Hospital Dubrava:
Colorectal cancer
Surgical stress response
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases