Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
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|ClinicalTrials.gov Identifier: NCT02572869|
Recruitment Status : Active, not recruiting
First Posted : October 9, 2015
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Other: physical exam Behavioral: questionnaires|
|Study Type :||Observational|
|Estimated Enrollment :||26 participants|
|Official Title:||Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps|
|Actual Study Start Date :||September 30, 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
segmental mandibulectomy and free fibular flap reconstruction
Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014
Other: physical exam
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.
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.
- Long-term functional (11-item clinical examination form which documents the patient's oral function) [ Time Frame: 1 year ]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.
- Long-term aesthetic outcome evaluated by photographs [ Time Frame: 1 year ]archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572869
|United States, New Jersey|
|Memoral Sloan Kettering Cancer Center|
|Basking Ridge, New Jersey, United States|
|United States, New York|
|Memorial Sloan Kettering West Harrison|
|Harrison, New York, United States, 10604|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Jatin Shah, MD||Memorial Sloan Kettering Cancer Center|