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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-06', 'studyFirstSubmitDate': '2013-10-23', 'studyFirstSubmitQcDate': '2013-10-28', 'lastUpdatePostDateStruct': {'date': '2017-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in inflammatory cytokines', 'timeFrame': 'pre-operative, at time of induction of anaethesia, 6,24 and 48 hours after the operation', 'description': 'Primary outcome measure is the change in inflammatory cytokines Tumor Necrosis Factor-alpha, interleukin -1, interleukin -6, interleukin -10'}], 'secondaryOutcomes': [{'measure': '30 postoperative day complications.', 'timeFrame': '30 days after operation', 'description': 'Secondary outcome measure is 30 postoperative day complications.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Surgery,Crohn's disease,Ulcerative colitis"], 'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '30390672', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nMethod: 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.", 'detailedDescription': "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.\n\nLaboratory variables\n\nThe following variables will be assessed based on previous evidence about their role in surgical stress response:\n\n1. Immunological parameters: Tumor necrosis factor-alpha, interleukin-1, interleukin-6, interleukin-10, C reactive protein, and white blood cell counts.\n2. Endocrinological parameters: plasma cortisol, growth hormone , adrenocorticotropic hormone, epinephrin and norepinephrine"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with Crohn disease, ulcerative colitis and indeterminate colitis undergoing elective abdominal surgery (laparoscopic or open)\n\nExclusion Criteria:\n\nNo patients will be excluded'}, 'identificationModule': {'nctId': 'NCT01974869', 'briefTitle': 'Anti Tumor Necrosis Factor Alpha Agents and Surgical Stress Response', 'organization': {'class': 'INDIV', 'fullName': 'El-Hussuna, Alaa, M.D.'}, 'officialTitle': 'The Effect of Anti-Tumor Necrosis Factor Agents on Surgical Stress Response in Inflammatory Bowel Disease Patients Undergoing Abdominal Surgery', 'orgStudyIdInfo': {'id': 'a-TNF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inflammatory bowel diseases-1', 'description': 'Treatment with anti-tumor necrosis factor alpha agents', 'interventionNames': ['Drug: Anti-tumor necrosis factor alpha agents']}, {'label': 'Inflammatory bowel diseases-2', 'description': 'Controls'}], 'interventions': [{'name': 'Anti-tumor necrosis factor alpha agents', 'type': 'DRUG', 'otherNames': ['Biologics'], 'description': 'Treatment with biologics', 'armGroupLabels': ['Inflammatory bowel diseases-1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Århus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Slagelse Hospitals', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Køge', 'country': 'Denmark', 'facility': 'Køge Hospital', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'city': 'Odense', 'country': 'Denmark', 'facility': 'OUH', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Alaa El-Hussuna', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Slagelse Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'To be planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'El-Hussuna, Alaa, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant surgeon', 'investigatorFullName': 'Alaa El-Hussuna', 'investigatorAffiliation': 'El-Hussuna, Alaa, M.D.'}}}}