Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01974869
• Other study ID #: a-TNF
• Status: Completed
• Phase: N/A
• First received: October 23, 2013
• Last updated: February 6, 2017
• Start date: March 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2017
• Source: El-Hussuna, Alaa, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Necrosis

Intervention

Drug:
• Anti-tumor necrosis factor alpha agents
Treatment with biologics

Locations

Country	Name	City	State
Denmark	Århus University Hospital	Århus
Denmark	Slagelse Hospitals	Copenhagen
Denmark	Køge Hospital	Køge
Denmark	OUH	Odense

Sponsors (1)

Lead Sponsor	Collaborator
El-Hussuna, Alaa, M.D.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 postoperative day complications.	Secondary outcome measure is 30 postoperative day complications.	30 days after operation