Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1012 for:    colon cancer AND resection
Previous Study | Return to List | Next Study

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.
 
ClinicalTrials.gov Identifier: NCT01244022
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : July 16, 2013
Sponsor:
Information provided by (Responsible Party):
Drazen Servis, University Hospital Dubrava

Tracking Information
First Submitted Date November 12, 2010
First Posted Date November 19, 2010
Last Update Posted Date July 16, 2013
Study Start Date August 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2010)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01244022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 18, 2010)
Early postoperative complications [ Time Frame: Within one month after surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cytokine Changes After Colorectal Cancer Resection
Official Title Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
For each patient, serum samples will be stored at -80°C for later determining of serum cytokine levels
Sampling Method Non-Probability Sample
Study Population Patients with colorectal cancer treated in the University Hospital Dubrava
Condition Colorectal Cancer
Intervention Procedure: colorectal cancer resection
Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
Other Names:
  • Hemicolectomy
  • Rectosigmoid resection
Study Groups/Cohorts Colorectal cancer patients
Patients with pathohistologically verified colorectal cancer or adenoma with epithelial dysplasia
Intervention: Procedure: colorectal cancer resection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2013)
28
Original Estimated Enrollment
 (submitted: November 18, 2010)
40
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Croatia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01244022
Other Study ID Numbers DS-P03112010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Drazen Servis, University Hospital Dubrava
Study Sponsor University Hospital Dubrava
Collaborators Not Provided
Investigators
Principal Investigator: Drazen Servis, M.D., Ph.D. University Hospital Dubrava
PRS Account University Hospital Dubrava
Verification Date July 2013