A Study to compare functional outcomes of Microscopic versus Endoscopic type 1 Tympanoplasty.
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- We hope to get – Good success rate after endoscopic Tympanoplasty in terms of graft uptake and hearing improvement .
Study Overview
Brief Summary
Tympanoplasty refers to any operation involving reconstruction of the tympanic membrane and/or the ossicular chain after eradication of disease.
The prevalence of Otitis media varies widely and causes a serious burden of illness globally. Chronic Suppurative Otitis Media (CSOM) accounts for a global burden of 65-330 million individuals with draining ears, 60% of whom suffer from significant hearing impairment.
Endoscopes make it possible to address the target pathology transcanal, while minimizing dissection of normal tissue done purely for exposure, leading to the evolution of minimally-invasive ear surgery and reducing morbidity.
As there are very few studies showing data of central india about endoscopic tympanoplasty, therefore we are doing this comparative study Between microscopic and endoscopic tympanoplasty.
We will be comparing their outcomes in terms of graft uptake and PTA at 3 months and 6 months interval post operatively.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed cases of COM mucosal in age group 18-65 yrs, with Central perforations , consenting for surgery.
Exclusion Criteria
- •Pregnant patients,smoker, known diabetic, any other comorbidities -COM squamosal. -Large Central perforation, subtotal or total perforations -Patient with Active ear discharge.
- •Patient with suspected ossicular discontinuity or fixation.
Outcomes
Primary Outcomes
We hope to get – Good success rate after endoscopic Tympanoplasty in terms of graft uptake and hearing improvement .
Time Frame: Follow up at 3 months and 6 months period after surgery
Less intraoperative and post operative pain.
Time Frame: Follow up at 3 months and 6 months period after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Shivangi Patnecha
All India institute of medical sciences AIIMS, Raipur