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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-08-16

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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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segmental mandibulectomy and free fibular flap reconstruction

Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 2014

physical exam

Intervention Type OTHER

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.

questionnaires

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No