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临床试验/CTRI/2024/10/074840
CTRI/2024/10/074840尚未招募不适用

A Comparative study of myringoplasty with and without cortical mastoidectomy in treatment of chronic otitis media without choleasteatoma

DR Rajendra Prasad Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年10月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
graft success rate

研究概览

简要总结

The World Health Organization defines chronic suppurative otitis media (CSOM) as a persistent middle ear infection with a perforated tympanic membrane, leading to chronic discharge and hearing loss. Globally, CSOM affects between 65 to 330 million people, with 60% experiencing significant hearing impairment. It causes about 28,000 deaths annually and results in over 2 million Disability-Adjusted Life Years (DALYs). The incidence is notably higher in developing countries due to factors like poor socio-economic conditions, inadequate nutrition, and lack of health education. In India, the prevalence is 46 per thousand in rural areas and 16 per thousand in urban areas, making it a major cause of hearing impairment in rural populations.

Effective management of CSOM often involves surgical intervention, particularly mastoidectomy combined with tympanoplasty. This approach aims to remove infected tissue, achieve a dry and healthy ear, and improve hearing outcomes. The success of tympanic membrane reconstruction largely depends on addressing any mastoid disease. The prevalence of CSOM is linked to poor living conditions, and surgical treatments can help reduce disease burden and improve quality of life by preventing recurrent infections and promoting hearing restoration.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with chronic ear discharge (Chronic Suppurative Otitis Media, safe type) attending the ENT OPD at Dr. RPGMC Tanda, Kangra.
  • Age group 18 to 60 years.
  • Both genders.
  • Unilateral or bilateral disease.

排除标准

  • Patients above the age of 60 years or below 18 years.
  • Chronic Suppurative Otitis Media, unsafe type.
  • Debilitated and immunocompromised patients.
  • Pregnant and lactating women.
  • Patients with external or middle ear abnormalities (congenital or acquired).

结局指标

主要结局

graft success rate

时间窗: baseline, 12 weeks and 24 weeks

hearing improvement

时间窗: baseline, 12 weeks and 24 weeks

reoccurrence of disease

时间窗: baseline, 12 weeks and 24 weeks

次要结局

未报告次要终点

研究者

发起方
DR Rajendra Prasad Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

VAISHALI GUPTA

Dr. Rajendra prasad medical College and hospital

研究点 (1)

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