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Cytokine Changes After Colorectal Cancer Resection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University Hospital Dubrava.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT01244022
First received: November 12, 2010
Last updated: February 14, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention
Colorectal Cancer
 Procedure: colorectal cancer resection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital Dubrava:

Primary Outcome Measures:
  • Postoperative changes of serum cytokine levels [ Time Frame: 1 day, 2 days and 7 days postoperatively ] [ Designated as safety issue: No ]
    Serum cytokine levels will be determined at 1st, 2nd and 7th postoperative day and compared to preoperative values.


Secondary Outcome Measures:
  • Early postoperative complications [ Time Frame: Within one month after surgery ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

For each patient, serum samples will be stored at -80°C for later determining of serum cytokine levels


Estimated Enrollment: 40
Study Start Date: August 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with colorectal cancer or adenomas treated in the University Hospital Dubrava

Criteria

Inclusion Criteria:

  • Pathohistologically verified colorectal cancer or adenoma with dysplasia

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244022

Contacts
Contact: Drazen Servis, M.D., Ph.D. ++ 385 1 290 3508 drazenservis@yahoo.com

Locations
Croatia
University Hospital Dubrava Recruiting
Zagreb, Croatia, 10000
Contact: Drazen Servis, M.D., Ph.D.     ++ 385 1 290 3508     drazenservis@yahoo.com    
Principal Investigator: Drazen Servis, M.D., Ph.D.            
Sponsors and Collaborators
University Hospital Dubrava
Investigators
Principal Investigator: Drazen Servis, M.D., Ph.D. University Hospital Dubrava
  More Information

Publications:

Responsible Party: Drazen Servis, M.D., Ph.D., University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT01244022     History of Changes
Other Study ID Numbers: DS-P03112010
Study First Received: November 12, 2010
Last Updated: February 14, 2011
Health Authority: Croatia: Ethics Committee

Keywords provided by University Hospital Dubrava:
Colorectal cancer
Surgical stress response
interleukins

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

ClinicalTrials.gov processed this record on May 23, 2013