Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

February 6, 2017 updated by: Alaa El-Hussuna, El-Hussuna, Alaa, M.D.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Slagelse Hospitals
      • Køge, Denmark
        • Køge Hospital
      • Odense, Denmark
        • OUH
      • Århus, Denmark
        • Århus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inflammatory bowel diseases-1
Treatment with anti-tumor necrosis factor alpha agents
Drug: Anti-tumor necrosis factor alpha agents
Treatment with biologics
Other Names:
  • Biologics
Inflammatory bowel diseases-2
Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in inflammatory cytokines
Time Frame: 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
pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30 postoperative day complications.
Time Frame: 30 days after operation
Secondary outcome measure is 30 postoperative day complications.
30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

El-Hussuna, Alaa, M.D.

Investigators

  • Principal Investigator: Alaa El-Hussuna, Slagelse Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

November 3, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • a-TNF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To be planned

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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