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NCT02572869 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02572869
Other study ID # 15-244
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2015
Est. completion date August 16, 2019

Study information
Verified date August 2019
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date August 16, 2019
Est. primary completion date August 16, 2019
Accepts healthy volunteers No
Gender All
Age group 25 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.
Behavioral:
• questionnaires
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.

Locations
Country Name City State
United States Memoral Sloan Kettering Cancer Center Basking Ridge New Jersey
United States Memorial Sloan Kettering West Harrison Harrison New York
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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