Evolution of Cholesteatoma Surgical Management After Adoption of Exclusive Endoscopic Ear Surgery: A Tertiary Center Experience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Rate of revision surgery for residual or recurrent cholesteatoma
研究概览
简要总结
This retrospective observational study describes the evolution of surgical management of middle-ear cholesteatoma at Nice University Hospital over a 12-year period (January 2012 to December 2023), following the introduction of exclusive endoscopic ear surgery (EES) in September 2017. The study compares disease control (residual disease, recurrence, revision surgery) and audiometric outcomes (air-bone gap) between the pre-EES period (January 2012 to August 2017) and the post-EES period (September 2017 to December 2023), and between exclusive endoscopic, microscopic, and combined surgical approaches within the post-EES period. The aim is to characterize the patterns of surgical approach selection and to derive a practical guide for the appropriate use of EES in everyday cholesteatoma surgery.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient operated for middle-ear cholesteatoma at the Department of Otolaryngology-Head and Neck Surgery, Nice University Hospital
- •Surgery performed between January 1, 2012 and December 31, 2023
- •Intraoperative confirmation of cholesteatoma
排除标准
- •Absence of cholesteatoma at intraoperative examination
- •Cholesteatoma originating outside the middle ear (e.g., external auditory canal cholesteatoma)
结局指标
主要结局
Rate of revision surgery for residual or recurrent cholesteatoma
时间窗: From index surgery up to 10 years of follow-up
Proportion of patients requiring revision surgery during follow-up for residual or recurrent cholesteatoma. Residual cholesteatoma is defined as disease attributable to incomplete removal at the index surgery, identified by diffusion-weighted magnetic resonance imaging (DW-MRI) surveillance and confirmed intraoperatively at revision surgery. Recurrent cholesteatoma is defined as disease arising from a new tympanic membrane retraction pocket or perforation, diagnosed by otoscopic examination with DW-MRI support when clinically indicated
次要结局
- Postoperative air-bone gap (ABG)(Preoperative, at 4 months postoperatively, and at 1 year postoperatively.)
- Percentage of cholesteatoma procedures performed with each surgical approach per year(Each calendar year of the study period (2012-2023))
- Number of participants managed with each surgical approach according to disease and patient characteristics(Post-EES period (September 2017 - December 2023))