Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
1 other identifier
observational
26
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 16, 2019
CompletedAugust 20, 2019
August 1, 2019
3.9 years
October 1, 2015
August 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
segmental mandibulectomy and free fibular flap reconstruction
Patients who underwent segmental mandibulectomy and free fibular flap reconstruction at MSK between 1987 and 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.
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.
Eligibility Criteria
All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jatin Shah, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 9, 2015
Study Start
September 30, 2015
Primary Completion
August 16, 2019
Study Completion
August 16, 2019
Last Updated
August 20, 2019
Record last verified: 2019-08