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

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ClinicalTrials.gov Identifier: NCT02572869
Recruitment Status : Completed
First Posted : October 9, 2015
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Other: physical exam Behavioral: questionnaires

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Actual Study Start Date : September 30, 2015
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.





Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients will be identified from the institutional databases. Preliminary queries indicate that approximately 61 patients are eligible and currently alive.
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jatin Shah, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02572869     History of Changes
Other Study ID Numbers: 15-244
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Mandible Reconstruction
Fibula Osteomyocutaneous Free Flaps
Quality of Life
15-244
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms