Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

Background: The immunologic response to stress is regulated by the cytokines. Anti-Tumor Necrosis Factor-α agents are antibodies directed against a key cytokine in the process angiogenesis and collagen synthesis. It is not known whether they intervene with surgical stress response increasing the rate of postoperative complications.

Method: Un-blinded prospective, non-interventional cohort single centre study including all the patients with Crohn's disease and Ulcerative Colitis undergoing abdominal surgery. Immunological and endocrinological parameters will measured in blood samples taken from these patients before and after surgery. Power calculations showed that 17 patients in each arm are needed.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Århus University Hospital, Aarhus, Denmark

About this study

The baseline patient characteristics will be evaluated based on pilot tested data extraction sheets. The assessment will include demographics, clinical data as well as laboratory work up. The Charlson morbidity index, will be used to assess co-morbidity, the Nutritional risk score (NRS) to assess nutrition status and the Harvey-Bradshaw index (HBI) to evaluate the activity of Crohn's disease. The duration of surgical procedure, along with the amount of blood transfused, will be recorded in all patients.

Laboratory variables

The following variables will be assessed based on previous evidence about their role in surgical stress response:

Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

Exclusion criteria

No patients will be excluded

Treatment and study plan

Anti-tumor necrosis factor alpha agents

Drug

Treatment with biologics

Other names: Biologics

Primary outcomes

changes in inflammatory cytokines

Time frame: pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation

Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10

Secondary outcomes

30 postoperative day complications.

Time frame: 30 days after operation

Secondary outcome measure is 30 postoperative day complications.

Sponsors and collaborators

Lead sponsor

El-Hussuna, Alaa, M.D.

Indiv

Registry information

Official study title

The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Nov 4, 2013
Registry last updated: Feb 7, 2017

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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