Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT02572869
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2015-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-19', 'studyFirstSubmitDate': '2015-10-01', 'studyFirstSubmitQcDate': '2015-10-08', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Long-term functional (11-item clinical examination form which documents the patient's oral function)", 'timeFrame': '1 year', 'description': "The examining physician will then complete an 11-item clinical examination form which documents the patient's oral function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech,drooling, diet, appearance, oral sensation, and shoulder movement."}, {'measure': 'Long-term aesthetic outcome evaluated by photographs', 'timeFrame': '1 year', 'description': 'archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.'}]}, 'conditionsModule': {'keywords': ['Mandible Reconstruction', 'Fibula Osteomyocutaneous Free Flaps', 'Quality of Life', '15-244'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the functional and esthetic outcomes in patients who had removal of a part of the lower jaw bone due to mouth cancer and reconstruction of the jaw bone with a bone ( fibula) from the leg at MSKCC between the years 1987 to 2014.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to read and write in the English language\n* Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014\n* Able to travel to the MSK outpatient clinic or have access to email, the MSK patient portal and a computer with a camera for the follow up examination by a physician and completion of the questionnaires.\n\nExclusion Criteria:\n\n* Patients who underwent marginal mandibulectomy\n* Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap\n* Patients who underwent mandibular reconstruction with soft tissue free flap'}, 'identificationModule': {'nctId': 'NCT02572869', 'briefTitle': 'Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps', 'orgStudyIdInfo': {'id': '15-244'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'segmental mandibulectomy and free fibular flap reconstruction', 'description': 'Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014', 'interventionNames': ['Other: physical exam', 'Behavioral: questionnaires']}], 'interventions': [{'name': 'physical exam', 'type': 'OTHER', 'description': "Patients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment.", 'armGroupLabels': ['segmental mandibulectomy and free fibular flap reconstruction']}, {'name': 'questionnaires', 'type': 'BEHAVIORAL', 'description': 'The participating patients will be asked to complete three questionnaires:\n\n(1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H\\&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes.', 'armGroupLabels': ['segmental mandibulectomy and free fibular flap reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memoral Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '10604', 'city': 'Harrison', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering West Harrison', 'geoPoint': {'lat': 40.96899, 'lon': -73.71263}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jatin Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}