Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-01-02 @ 5:39 AM
Study NCT ID:
NCT04069650
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058752', 'term': 'Free Tissue Flaps'}], 'ancestors': [{'id': 'D013524', 'term': 'Surgical Flaps'}, {'id': 'D019738', 'term': 'Surgically-Created Structures'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-23', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-08-23', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major complication occurency', 'timeFrame': '1 month', 'description': 'in the first-month post-operative period, complications leading to flap loss'}], 'secondaryOutcomes': [{'measure': 'Minor complication occurency', 'timeFrame': '1 month', 'description': 'in the first-month post-operative period, complications NOT leading to flap loss'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Free Flap Reconstruction']}, 'descriptionModule': {'briefSummary': 'Free flap reconstruction consists in replacing tissular defect from one body part by another tissu harvested in a distant site. Microsurgery has to be performed to restore vascularization.\n\nFree flaps are now the gold standard in complex reconstruction. While reliable with a success rate superior to 95 %, a failure takes a heavy burden on the patient. Many risk factors have been highlitghted in free flap failure for head and neck microvascular reconstruction.\n\nAmong them, malnutrition is still debated. This is a retrospective cohort study comparing complications occurrence between two groups. One group with normal nutritionnal status, the other with malnutrition. Between january 2008 and january 2018, 70 patients who underwent oral cavity reconstruction using free flap were included. This is the first study known to date which uses clinical and biological variables to determine the nutritionnal status.\n\nMalnutrition is not associated with a higher risk for free flap failure in the oral cavity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing free flap reconstruction of the oral cavity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* every consenting patients undergoing free flap reconstruction of the oral cavity\n\nExclusion Criteria:\n\n* unable to give consent'}, 'identificationModule': {'nctId': 'NCT04069650', 'acronym': 'FOOD', 'briefTitle': 'Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Malnutrition is Not a Risk Factor for Free Flap Failure in the Oral Cavity', 'orgStudyIdInfo': {'id': 'ZWETYENGA 2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'None-malnutrition', 'description': 'normal nutritionnal status', 'interventionNames': ['Procedure: Free flap']}, {'label': 'Malnutrition', 'description': '* weight loss was superior to 5% in the past month;\n* a weight loss was superior to 10% in the past 6 months;\n* a BMI was inferior to 18,5 kg/m² (if age inferior to 70 years old) or inferior to 21 kg/m² (if age superior to \\> 70 years old) - a serum albumin level inferior to 30g/L (if age inferior to 70 years old) or inferior to \\<35g/L (if age superior to 70 years old).', 'interventionNames': ['Procedure: Free flap']}], 'interventions': [{'name': 'Free flap', 'type': 'PROCEDURE', 'description': 'Free flap reconstruction of the oral cavity', 'armGroupLabels': ['Malnutrition', 'None-malnutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourgogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}