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临床试验/CTRI/2026/03/105394
CTRI/2026/03/105394尚未招募3 期

A randomised controlled trial comparing quality of life outcomes following endaural inside out mastoidectomy and postaural outside in mastoidectomy approaches

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2026年3月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
64
试验地点
1

研究概览

简要总结

Both inside-out mastoidectomy and outside-in mastoidectomy techniques are established for treating chronic middle ear disease, but they differ in their extent of disease clearance, technical demand, and preservation of healthy structures. While Inside-out mastoidectomy is more targeted, often preserving more healthy bone and soft tissue, potentially resulting in improved post-operative cosmesis, on the other hand, Outside-in mastoidectomy provides systematic and extensive disease clearance, which may, however, result in greater changes to post-operative ear anatomy, which could negatively impact cosmesis. Assessment of pain, hearing improvement, and disease control are central to understanding the overall benefit of each method, but quality of life and patient satisfaction incorporating cosmesis are often underreported in literature comparing these techniques. By evaluating these outcomes side-by-side, we may highlight the need for considering both clinical objectives and patient-perceived benefits when planning a mastoidectomy surgery, paving the way for a more holistic treatment of chronic middle ear disease

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adults aged more than 18 years 2)Diagnosed COM requiring canal wall down mastoidectomy.

排除标准

  • Age less than 18 years 2) Patient not fit for surgery 3) Prior mastoid surgery on the same ear 4) Complicated COM 5) Unwillingness to consent.

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Khushi Gupta

All India Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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