Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT01974869
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2013-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
Sponsor:
El-Hussuna, Alaa, M.D.
Organization:
Study Overview
Official Title:
The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: