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Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response

NCT01974869 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 47

Last updated 2017-02-07

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Anti-tumor necrosis factor alpha agents

Treatment with biologics

Sponsors & Collaborators

  • El-Hussuna, Alaa, M.D.

    lead INDIV

Principal Investigators

  • Alaa El-Hussuna · Slagelse Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01974869 on ClinicalTrials.gov