Cytokine Changes After Colorectal Cancer Resection

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: Colorectal Cancer
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	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	Within one month after surgery

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Servis D, Busic Z, Stipancic I, Patrlj L, Gagro A. Serum cytokine changes after gastric resection or gastrectomy for gastric cancer. Hepatogastroenterology. 2008 Sep-Oct;55(86-87):1868-72.
• Etherek L, Servis D, Unic A. Soluble Triggering Receptor Expressed on Myeloid Cells-1 and Inflammatory Markers in Colorectal Cancer Surgery: A Prospective Cohort Study. Chin Med J (Engl). 2017 Nov 20;130(22):2691-2696. doi: 10.4103/0366-6999.218022.

Study record dates

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: Colorectal cancer; interleukins; Surgical stress response
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: DS-P03112010