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临床试验/NCT05182268
NCT05182268已完成不适用

Comparison of Clinical Effect Between Endoscopic and Microscopic Ear Surgery of Cholesteatoma: A Multicenter Retrospective Observational Study

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University0 个研究点目标入组 186 人开始时间: 2016年11月1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
186
主要终点
Pure Tone Average(PTA)

研究概览

简要总结

Background: Cholesteatoma is a potentially life-threatening inflammatory lesion that causes hearing loss, ear discharge, and ear pain, and serious complications. For the past several decades, most studies of cholesteatoma have been restricted to microscopic ear surgery. However, a growing body of evidence suggests endoscopic ear surgery is a safe, minimally invasive approach for cholesteatoma management. This thesis aim to investigate and compare the clinical effect between endoscopic and microscopic ear surgery of cholesteatoma.

Materials and methods: The retrospective study included 186 patients with cholesteatoma who received endoscopic or microscopic ear surgery from 11 otorhinolaryngology centers between November 2016 and March 2021. Patients were followed-up for at least 1 year. Audiometry improvement, treatment cost, time, graft success rate and recurrence rate were assessed after 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
6 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • postoperative pathologically were confirmed cholesteatoma with or without mastoid involvement
  • the extent of disease was confirmed by preoperative HRCT temporal bone
  • undergoed microscopic and/or endoscopic surgery for cholesteatoma including primary or revision surgery

排除标准

  • were lacking in clinical characteristics
  • had not preoperative audiometric data
  • missed the follow-up data
  • were lacking in surgical times
  • were microscopic combined endoscopic ear surgery

结局指标

主要结局

Pure Tone Average(PTA)

时间窗: at least 1 year

estimate the auditory acuity

Air-Bone Gap(A-B Gap)

时间窗: at least 1 year

estimate the auditory acuity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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