Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-29 @ 10:18 AM
Study NCT ID:
NCT03346928
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2017-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Free Flaps : Should we Propose Them to the Elderly ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2017-11-15', 'studyFirstSubmitQcDate': '2017-11-17', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical complications', 'timeFrame': 'One month post-surgery', 'description': 'Occurrence of medical complications within one month post-surgery'}], 'secondaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': 'One month post-surgery', 'description': 'Occurrence of surgical complications within one month post-surgery'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Approximately 20 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction.', 'detailedDescription': 'The objective was to evaluate perioperative morbidity after head and neck microsurgical reconstruction. A retrospective chart review of all patients undergoing head and neck free flap reconstruction was conducted and the overall hospital length of stay and the incidence of perioperative medical and surgical complications were assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with head and neck cancer undergoing microsurgical free flap reconstruction', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and neck cancer\n* Microsurgical free flap reconstruction\n* 18 years of age or older\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03346928', 'briefTitle': 'Free Flaps : Should we Propose Them to the Elderly ?', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Free Flaps for Head and Neck Reconstruction : Should we Propose Them to the Elderly', 'orgStudyIdInfo': {'id': 'CRC_GHN_2017_003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Head and neck reconstruction', 'type': 'PROCEDURE', 'description': 'Head and neck free flap reconstruction'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Croix-Rousse Hospital, Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}