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临床试验/CTRI/2022/11/047120
CTRI/2022/11/047120尚未招募不适用

Endoscopic versus Microscopic tympanoplasty: A randomized control trial

ROHILKHAND MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年11月15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
210
试验地点
1
主要终点
Graft success rate

研究概览

简要总结

Chronic otitis media is the inflammation of mucous membrane of middle ear cleft. It presents with permanent abnormality in pars tensa or flaccida. According to WHO 65-330 million people world wide suffer from CSOM of whom 50% suffer from hearing impairement and 28000 people die per year. The hearing impairement is usually preventable if preferred  intervention is taken on time  . The management of chronic otitis media depends on the type of chronic otitis media .

The main aim of surgery in chronic otitis media is to decrease hearing disability in the patient.

Tympanoplasty is the surgery of choice amongst mucosal type of chronic otitis media. Tympanoplasty is a procedure to remove disease from middle ear and reconstruct hearing with or without tympanic membrane grafting.

Conventionally Microscopic tympanoplasty is being used and still in practice for surgery  for TM perforations . But since the introduction of endoscopes  in the 1990s ,endoscopic tympanoplasty is emerging as an alternative for microscopic tympanoplasty. Microscopes provide the benefit of using both hands to perform surgery but with the limitation of narrow view of the surgical field and inability to access deeper areas which is possible with the use of endocopes. Though it suffers from this limitation , the use of only one hand in endoscopic surgery limits endoscope use as there is  hesitancy among surgeons regarding efficacy and safety of endoscopes  along with the need of special training and experience to use endoscopes.

Microscopic tympanoplasty is performed through postauricular incision which increases hospital stay and discomfort of the patient whereas the use of endoscopes have reduced surgery time , hospital stay and post operative pain due to its minimally invasive procedure.

The concerns regarding depth perception , steeper learning curve and chance of injury by the light source , fogging of the lens during surgery, is a limitation to endoscopic surgery.

Since, there is limited literature present on this topic which compares both endoscopic and microscopic tympanoplasty. So to fill this lacunae the present study has been undertaken.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

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

入选标准

  • All patients willing to participate in the study.

排除标准

  • All patients above the age of 60 years.
  • Patients suffering from diabetes , hypertension, tuberculosis , any immunocompromised disease .

结局指标

主要结局

Graft success rate

时间窗: At 3 months

次要结局

  • Hearing level

研究者

发起方
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL
申办方类型
Private medical college

研究点 (1)

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