Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response
NCT ID: NCT01974869
Last Updated: 2017-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2014-03-31
2016-08-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Inflammatory bowel diseases-1
Treatment with anti-tumor necrosis factor alpha agents
Anti-tumor necrosis factor alpha agents
Treatment with biologics
Inflammatory bowel diseases-2
Controls
No interventions assigned to this group
Interventions
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Anti-tumor necrosis factor alpha agents
Treatment with biologics
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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El-Hussuna, Alaa, M.D.
INDIV
Responsible Party
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Alaa El-Hussuna
Consultant surgeon
Principal Investigators
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Alaa El-Hussuna
Role: PRINCIPAL_INVESTIGATOR
Slagelse Hospital
Locations
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Århus University Hospital
Aarhus, , Denmark
Slagelse Hospitals
Copenhagen, , Denmark
Køge Hospital
Køge, , Denmark
OUH
Odense, , Denmark
Countries
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References
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El-Hussuna A, Qvist N, Zangenberg MS, Langkilde A, Siersma V, Hjort S, Gogenur I. No effect of anti-TNF-alpha agents on the surgical stress response in patients with inflammatory bowel disease undergoing bowel resections: a prospective multi-center pilot study. BMC Surg. 2018 Nov 3;18(1):91. doi: 10.1186/s12893-018-0425-0.
Other Identifiers
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a-TNF
Identifier Type: -
Identifier Source: org_study_id
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