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临床试验/CTRI/2017/08/009199
CTRI/2017/08/009199招募中不适用

Comparison of The Efficacy of Endoscopic versus Microscopic Myringoplasty in Management of Pars Tensa Perforations: A Randomized Clinical Trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2016年9月26日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
108
试验地点
1
主要终点
To compare hearing outcome in both the groups in the treatment of CSOM TTD

研究概览

简要总结

Comparision of the efficacy of endoscopic versus Microscopic Myringoplasty in the management of pars tensa perforations : A Randomised clinical trial.

Closure of tympanic membrane perforations in the pars tensa region in a case of CSOM tubo tympanic type disease is known as myringoplasty. Various advancements in this surgery are now available and here we compare 2 novel procedures done for the treatment of pars tensa perforations. Hearing outcomes after both types of surgery will be assessed as the primary outcome and graft uptake will be the secondary outcome of this study. Block randomization will be followed. Data collection will be done and patient will be followed up post operatively at 8 weeks and 3 months for hearing assessment and graft uptake.Unpaired t test will be used to compare hearing outcomes between both the groups.Graft uptake will be statistically assessed by the chi square test or fischers test. This study aims to show both the techniques used for pars tensa perforation repair and advantages and disadvantages of each.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All diagnosed cases of CSOM TTD with pars tensa perforation and conductive hearing loss in the age group of 18 to 50 years of both sex in JIPMER hospital.

排除标准

  • Patients with active discharge from middle ear 2 CSOM of attico antral type
  • Patients with otitis externa
  • Patients with sensorineural hearing loss or mixed type hearing loss 5 Patients with abnormalities in ossicular chain 6 Patients with nasal allergy, bleeding diathesis, diabetes, hypertension.

结局指标

主要结局

To compare hearing outcome in both the groups in the treatment of CSOM TTD

时间窗: Pre operative | 8 weeks | 3 months

次要结局

  • To compare graft uptake between both the groups(8 weeks)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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