A clinical trial to compare the results of two techniques (single and double flap technique) of endoscopic tympanoplasty - an ear surgery.
Phase 2
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/12/038620
- Lead Sponsor
- Maulana Azad Medical College and associated Lok Nayak Hospital GIPMER GNEC New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1.Age group >18 years & = 60 years
2.Grade III and Grade IV tympanic membrane perforations.
3.Dry ear
4.Good cochlear reserve
Exclusion Criteria
1.Active mucosal disease
2.Atticoantral disease
3.Revision ear surgery
4.Active nasopharynx or sinus infection
5.Extensive tympanosclerosis
6.Suspected ossicular involvement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft uptake rate at 3 months after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.Timepoint: 3 months after the intervention (surgery)
- Secondary Outcome Measures
Name Time Method Change in air conduction- bone conduction gap (AB gap) after endoscopic single flap tympanoplasty in comparison with endoscopic double flap tympanoplasty.Timepoint: 3 months after the intervention(surgery)