NL-OMON47835招募中不适用
Cost effectiveness of follow-up with diffusion-weighted MRI versus surgical follow-up after cholesteatoma treatment. - Cost effectiveness of MRI diffusion in cholesteatoma follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 153
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria RCT
- •* 18 years of age or older.
- •* patients who underwent a surgical procedure (canal wall up tympanoplasty) for eradication of primary or recurrent acquired cholesteatoma
- •* primary surgery at a maximum of 11 months prior to the start of the study.
- •* patients with normal to mild conductive hearing loss, defined as:
- •mean air-bone gap of less than or equal to (*) 20dB on pure tone audiometry at frequencies of 0.5, 1 and 2 kHz .
- •* capable and willing to participate in a follow-up study of three years
排除标准
- •* patients who underwent a canal wall down tympanoplasty procedure as last ear surgical procedure (patients with a canal wall down procedure in the last 10 months will be requested to participate in the cholesteatoma observational study, which is an anonymous follow-up study of usual care in post-cholesteatoma surgery patients without randomization);* patients with a moderate to severe average air-bone gap of more than (>) 20 dB (patients eligible for a chain reconstruction will be requested to participate in the cholesteatoma observational study);* patients not capable to undergo a MRI (claustrophobic, metal parts or implants in the body etc.)
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Cost effectiveness of MRI diffusion in cholesteatoma follow-upENG: Cholesteatoma, MRI, Hearing, Cost-effectiveness, Quality of Life, QALYDUTCH: Cholesteatoom, MRI, Gehoor, Kosteneffectiviteit, Kwaliteit van Leven, QALYNL-OMON26889Vrije Universiteit Medisch Centrum153
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