Cytokine Changes After Colorectal Cancer Resection

Colorectal Cancer Clinical Trial

Official title:

Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244022
• Other study ID #: DS-P03112010
• Status: Completed
• Phase: N/A
• First received: November 12, 2010
• Last updated: July 15, 2013
• Start date: August 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• colorectal cancer resection
Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Early postoperative complications		Within one month after surgery	No