NCT02969993已完成不适用
Very Long Term VHI Voice Outcome After MTIS
Cliniques universitaires Saint-Luc- Université Catholique de Louvain6 个研究点 分布在 2 个国家目标入组 53 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Voice handicap index
研究概览
简要总结
Long term assesment of voice outcome after Montgomery Thyroplastie by performing a Survey of operated patients using the voice handicap index scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting UVFP of neurogenic origin treated by MTIS > 2 years before inclusion.
- •No superior limit in terms of years.
- •Age 18-80 years at the time of MTIS
- •No other treatment before MTIS other than resorbing material injection laryngoplasty (maximum twice)
- •No further voice treatment after MTIS except speech therapy.
- •VHI or VHI-10 performed before MTIS and within the 6 months after MTIS. In case of multiple post-op VHI tests, only the earliest post-op. VHI test will be taken into account
- •VHI tests validated for the utilized language
排除标准
- •patient not able to answer VHI questionnaire personally
- •Post MTIS new health condition affecting the voice tract and/ or the respiratory function.
- •Post MTIS appearance of other voice/ vocal cord pathology
研究组 & 干预措施
Questionnaire
Experimental
Questionnaire to previously operated patients
干预措施: Questionnaires (Other)
结局指标
主要结局
Voice handicap index
时间窗: 2 years
Questionnaire
次要结局
未报告次要终点
研究者
研究点 (6)
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