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