A trial which randomly assign patients needing stapes surgery to either endoscopic or microscopic procedures to see which one yields better results in terms of hearing improvement, complications, surgery duration, post-operative pain, and patient satisfactio
Not Applicable
- Conditions
- Health Condition 1: H743- Other acquired abnormalities of ear ossicles
- Registration Number
- CTRI/2024/04/066041
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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 18 - 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
Exclusion Criteria
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the outcomes of endoscopic and microscopic stapes surgery in terms of post op hearing improvement. <br/ ><br>To compare the various intraoperative and postoperative complications of endoscopic and microscopic stapes surgery <br/ ><br>Timepoint: At pack removal (post op day 7), after 1 month and 3 months post surgery <br/ ><br>
- Secondary Outcome Measures
Name Time Method 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.Timepoint: 1 day