Cytokine Changes After Colorectal Cancer Resection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Drazen Servis, University Hospital Dubrava
ClinicalTrials.gov Identifier:
NCT01244022
First received: November 12, 2010
Last updated: July 15, 2013
Last verified: July 2013
  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:


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


Enrollment: 28
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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 treated in the University Hospital Dubrava

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Croatia
University Hospital Dubrava
Zagreb, Croatia, 10000
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: July 15, 2013
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 August 26, 2014