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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02572869
Enrollment
26
Registered
2015-10-09
Start date
2015-09-30
Completion date
2019-08-16
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

Mandible Reconstruction, Fibula Osteomyocutaneous Free Flaps, Quality of Life, 15-244

Brief 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.

Interventions

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.

BEHAVIORALquestionnaires

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.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Long-term functional (11-item clinical examination form which documents the patient's oral function)1 yearThe 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 photographs1 yeararchival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026