跳至主要内容
临床试验/CTRI/2025/07/091865
CTRI/2025/07/091865尚未招募不适用

Comparative Outcomes of Tympanoplasty in Patients with Eustachian Tube Dilation vs. Without Eustachian Tube Dilation Using Saccharine test for Diagnosing Eustachian Tube Dysfunction: A Randomised Control Trial

All India Institute Of Medical Sciences Bathinda1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年8月11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
32
试验地点
1
主要终点
To determine graft uptake rates among patients with eustachian tube dysfunction who undergo

研究概览

简要总结

Tympanoplasty is a surgical procedure done for repairing of perforated tympanic membrane i.e eardrum along with repair of middle ear structures, eustachian tube dysfunction is a common condition which affects the capacity of middle ear to regulate air pressure and drain fluids collected in middle ear which leads to persistent ear problems and compromising the outcome of ear surgeries including tympanoplasty , the Eustachian tube plays a major role in regulating the pressure within the middle ear., failure to mark eustachian tube dysfunction may cause recurrent ear infections, middle ear effusions, and unfavourable outcomes post tympanoplasty. Recent innovations like eustachian tube dilation aims to address the dysfunction by improving its function which can be done preoperatively or intraoperatively. In this study we explore the effectiveness of intraoperative eustachian tube dilation using saccharine as guide to assess eustachian tube dysfunction preoperatively. The saccharine test involves instillation of saccharine pellet through perforated tympanic membrane and monitoring its detection in the throat after passage through eustachian tube. Objective is to find out whether intraoperative eustachian tube dilation improves surgical outcome for tympanoplasty compared to those who do not undergo eustachian tube dilation? The hypothesis is that eustachian tube dilation using balloon technique and using saccharine as guide will result in significant better surgical outcomes for tympanoplasty, with better graft uptake and better hearing improvement compared to patients who do not undergo dilation.Tympanoplasty is a surgical procedure done for repairing of perforated tympanic membrane i.e eardrum along with repair of middle ear structures, eustachian tube dysfunction is a common

condition which affects the capacity of middle ear to regulate air pressure and drain fluids collected in middle ear which leads to persistent ear problems and compromising the outcome of ear surgeries including tympanoplasty , the Eustachian tube plays a major role in regulating the pressure within the middle ear., failure to mark eustachian tube dysfunction may cause recurrent ear infections, middle ear effusions, and unfavourable outcomes post tympanoplasty. Recent innovations like eustachian tube dilation aims to address the dysfunction by improving its function which can be done preoperatively or intraoperatively. In this study we explore the effectiveness of intraoperative eustachian tube dilation using saccharine as guide to assess eustachian tube dysfunction preoperatively. The saccharine test involves instillation of saccharine pellet through perforated tympanic membrane and monitoring its detection in the throat after passage through eustachian tube. Objective is to find out whether intraoperative eustachian tube dilation improves surgical outcome for tympanoplasty compared to those who do not undergo eustachian tube dilation? The hypothesis is that eustachian tube dilation using balloon technique and using saccharine as guide will result in significant better surgical

outcomes for tympanoplasty, with better graft uptake and better hearing improvement compared to patients who do not undergo dilation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Adult patients aged 18 to 50 years with a perforation of the tympanic membrane.
  • Patients with eustachian tube dysfunction identified using saccharine test.

排除标准

  • Patient refusal of consent Patients with chronic middle ear disease, cholesteatoma.
  • Previous ear surgeries (except for minor procedures).
  • eustachian tube defects due to anatomical abnormalities Patients with normal saccharine test time Patients with immunocompromised conditions- diabetic, hypertensive, HIV, autoimmune diseases.
  • Patients with nasal pathologies ( polyps, afrs).

结局指标

主要结局

To determine graft uptake rates among patients with eustachian tube dysfunction who undergo

时间窗: To determine graft uptake rates with no residual perforation at 1 week, 1 month , 3 month and 6 month

eustachian tube dilatation and those who do not.

时间窗: To determine graft uptake rates with no residual perforation at 1 week, 1 month , 3 month and 6 month

次要结局

  • To assess improvement in air bone gap closure in both groups.(To assess complications postoperatively(e.g., recurrence of perforation, hearing loss) in both)

研究者

发起方
All India Institute Of Medical Sciences Bathinda
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Vasista Padhi

All India Institute Of Medical Sciences Bathinda

研究点 (1)

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