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A clinical trial to compare the outcomes of 2 types of tympanoplasty in terms of improvement in hearing and non discharging ear, the conventional tympanoplasty and total annular excision tympanoplasty

A randomized control study to compare the outcomes of total annular excision tympanoplasty and conventional tympanoplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041917
Enrollment
60
Registered
2022-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: total annular excision tympanoplasty: the remaining annulus of the tympanic membrane shall be removed and graft placed over the bony annulus. PTA and otoscopy shall be done after 3 mont

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic otitis media of the mucosal type with large, subtotal and total perforations. Air bone gap in pure tone audiometry > 20 dB

Exclusion criteria

Exclusion criteria: 1.Patients having active discharge at presentation 2.Patients having history of previous surgeries on the same side of planned operation 3.Patients having small central perforations 4.Age less than 18 years and more than 60 years 5.Patients having sensorineural component in Pure tone audiogram.

Design outcomes

Primary

MeasureTime frame
1.Graft uptake will be measured by otoscopy 2.Hearing gain will be measured by pure tone audiometry. 3.Quality of life assessment scores using questionnaire prepared by the investigator ( based on chronic ear survey by Massachusetts Eye and Ear) Timepoint: 2 weeks, 1 month and 3 months—

Secondary

MeasureTime frame
quality of life assessment scores using questionnaire prepared by the investigator ( based on chronic ear survey by Massachusetts Eye and Ear) Timepoint: 2 week, 1 month, 3 months—

Countries

India

Contacts

Public ContactDr Anwer Shah P A

AIIMS BHUBANESWAR

doc.sauravsarkar@gmail.com9497443883

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026