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Completed

NCT Number: NCT01244022

Cytokine Changes After Colorectal Cancer Resection

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Dubrava

Zagreb, 10000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

colorectal cancer resection

Procedure

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

Other names: Hemicolectomy, Rectosigmoid resection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Early postoperative complications

    Time frame: Within one month after surgery

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

Postoperative Serum Cytokine Changes After Radical Resection of Colorectal Cancer

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 19, 2010
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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