Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps

Study Overview
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Brief Summary
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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.

Official Title
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Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: physical exam
* Behavioral: questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read and write in the English language Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014 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. Exclusion Criteria: Patients who underwent marginal mandibulectomy Patients who underwent mandibular reconstruction with a different type of vascularized bone free flap Patients who underwent mandibular reconstruction with soft tissue free flap

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| segmental mandibulectomy and free fibular flap reconstruction<br>Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014 | Other: physical exam<br>* 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.<br>Behavioral: questionnaires<br>* The participating patients will be asked to complete three questionnaires: (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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term functional (11-item clinical examination form which documents the patient's oral function) | 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. | 1 year | 
| Long-term aesthetic outcome evaluated by photographs | archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mandible Reconstruction, Fibula Osteomyocutaneous Free Flaps, Quality of Life, 15-244