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临床试验/NCT02572869
NCT02572869已完成不适用

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

Memorial Sloan Kettering Cancer Center3 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
3
主要终点
Long-term aesthetic outcome evaluated by photographs

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Long-term aesthetic outcome evaluated by photographs

时间窗: 1 year

archival patient photographs taken shortly after the reconstructive surgery will be compared with photographs taken at the time of study assessment.

Long-term functional (11-item clinical examination form which documents the patient's oral function)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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