跳至主要内容
临床试验/CTRI/2024/04/066041
CTRI/2024/04/066041尚未招募不适用

A Randomized Control Trial to compare the outcomes of endoscopic and microscopic stapes surgery

All India Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
To compare the outcomes of endoscopic and microscopic stapes surgery in terms of post op hearing improvement.

研究概览

简要总结

Otosclerosis is a hereditary localized disease of the bone formed from the otic capsule characterized by alternating phases of bone formation and resorption. Treatment options for otosclerosis include medical management (NaF), hearing aids and surgery. While hearing aids can effectively manage the condition in its early stages, surgery may become necessary for a more definitive solution. Traditionally, stapedotomy is performed using an operating microscope and is the established treatment for otosclerosis. However, with the introduction of endoscopes, an increasing number of medical centers are performing endoscopic stapedotomy. The primary aim of my study is to

  1. To compare the outcomes of  endoscopic  and microscopic stapes surgery in terms of post op hearing improvement.

  2. To compare the various intraoperative and postoperative complications of  endoscopic  and microscopic stapes surgery

The secondary aim of the study is to assess the visualization of various middle ear structures in order to understand the easiness of stapes surgery between endoscopic and microscopic stapes surgery in a trainee point of view.

When a patient is following up in the department of Otorhinolaryngology-Head and Neck Surgery and planned for surgery, his consent will be taken to participate in the study. After his consent is taken, we will ask them a set of questions, which includes their demographics, personal, family history and clinical history. After assessing his medical history and performing a clinical examination, he will be randomized to either microscopic stapes surgery group or endoscopic stapes surgery group and undergo stapes surgery . The outcome and complications of their surgery will be assessed and studied.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients who are diagnosed with otosclerosis based on clinical history, examination and audiological assessment and opting for surgery. Patient with normal otoscopy findings Patient aged between
  • 50 years Absent history of past middle ear infection diseases/past ear surgeries Patients undergoing stapes surgery under Local Anesthesia Only primary cases are included Patient willing to give written informed consent for surgery and to be part of the study.

排除标准

  • Patients with extreme of ages less than 18 years of age and greater than 50 years of age Patients with other causes of hearing loss.
  • Patients with external ear and other middle ear pathologies.
  • Patients with comorbidities deeming them unfit for local anesthesia.

结局指标

主要结局

To compare the outcomes of endoscopic and microscopic stapes surgery in terms of post op hearing improvement.

时间窗: At pack removal (post op day 7), after 1 month and 3 months post surgery

To compare the various intraoperative and postoperative complications of endoscopic and microscopic stapes surgery

时间窗: At pack removal (post op day 7), after 1 month and 3 months post surgery

次要结局

  • To assess the visualization of various middle ear structures in order to understand the easiness of stapes surgery between endoscopic and microscopic stapes surgery in a trainee point of view.(1 day)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Thalhath A Salam

AIIMS New Delhi

研究点 (1)

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