Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: Anti-tumor necrosis factor alpha agents


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory bowel diseases-1<br>Treatment with anti-tumor necrosis factor alpha agents | Drug: Anti-tumor necrosis factor alpha agents<br>* Treatment with biologics<br>* Other names: Biologics;|
| Inflammatory bowel diseases-2<br>Controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in inflammatory cytokines | Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10 | pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 postoperative day complications. | Secondary outcome measure is 30 postoperative day complications. | 30 days after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery,Crohn's disease,Ulcerative colitis