Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
- Conditions
- Inflammatory Bowel Diseases
- Interventions
- Drug: Anti-tumor necrosis factor alpha agents
- Registration Number
- NCT01974869
- Lead Sponsor
- El-Hussuna, Alaa, M.D.
- Brief Summary
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
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:
1. Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.
2. Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)
No patients will be excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Inflammatory bowel diseases-1 Anti-tumor necrosis factor alpha agents Treatment with anti-tumor necrosis factor alpha agents
- Primary Outcome Measures
Name Time Method changes in inflammatory cytokines 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 Outcome Measures
Name Time Method 30 postoperative day complications. 30 days after operation Secondary outcome measure is 30 postoperative day complications.
Trial Locations
- Locations (4)
Køge Hospital
🇩🇰Køge, Denmark
Århus University Hospital
🇩🇰Århus, Denmark
Slagelse Hospitals
🇩🇰Copenhagen, Denmark
OUH
🇩🇰Odense, Denmark