Overview

Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
El-Hussuna, Alaa, M.D.
Criteria
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