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A Study to Compare the Result of Placing the Graft on the Inner side and the Outer side of the Bone in the Ear in Ear Drum Perforation Surgeries.

A Study Comparing the outcomes of Graft Placement Medial and Lateral to the Handle of Malleus in Type 1 Tympanoplasty Underlay Technique. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081149
Enrollment
40
Registered
2025-02-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Control Intervention1: graft placed over the handle of malleus: patient undergoing type 1 tympanoplasty where graft will be placed over the handle of malleus which will be done for 1 year Control Inte

Sponsors

Dr. Kritika Agrawal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient admitted and willing for procedure Patients with inactive chronic otitis media tubotympanic disease. Patients with isolated conductive hearing loss with an Air bone gap of less than 45dB. Dry ear for atleast 6 weeks Small or medium sized central perforation in tympanic membrane

Exclusion criteria

Exclusion criteria: Patients with recurrent chronic otitis media after previous surgery. Patient with ossicular disruption. Patients with complications of chronic otitis media. Patients with uncontrolled co-morbidities like diabetes mellitus, systemic hypertension, and Bronchial asthma, tuberculosis.

Design outcomes

Primary

MeasureTime frame
To determine the graft uptake rate in both techniquesTimepoint: 1 year—

Secondary

MeasureTime frame
To compare the hearing improvement in both techniques.Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Saquib Reyaz Khan

Varun Arjun Medical College and Rohilkhand Hospital

Poornimasbhat86@gmail.com7867834401

Outcome results

None listed

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