Clinical trial NCT01244022: Cytokine Changes After Colorectal Cancer Resection
Official title: Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Surgical stress response
interleukins
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer treated in the 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.

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 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

Primary outcomes:
measure: Postoperative changes of serum cytokine levels
timeFrame: 1 day, 2 days and 7 days postoperatively
Secondary outcomes:
measure: Early postoperative complications
timeFrame: Within one month after surgery
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Drazen Servis, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.