Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty

NCT ID: NCT07149480

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-07-09

Brief Summary

Chronic otitis media is a long-term ear infection that may cause a hole in the eardrum, leading to repeated ear discharge and hearing loss. When such perforations do not heal on their own, surgery called tympanoplasty is performed to repair the eardrum and improve hearing.

There are different surgical techniques for tympanoplasty. In the underlay technique, the graft (a small piece of tissue used to repair the hole) is placed beneath the layers of the eardrum. This approach is simpler and commonly used, but it carries risks such as displacement of the graft. In the interlay technique, the graft is positioned between specific layers of the eardrum, which may allow more natural healing and better hearing results, but it is technically more demanding.

This clinical study will compare the postoperative outcomes of these two techniques-interlay and underlay-among adults with large central perforations of the eardrum caused by chronic otitis media. The main outcomes assessed will include hearing improvement (measured by closure of the air-bone gap on hearing tests).

We hypothesize that the placement of the graft significantly influences surgical success and hearing recovery. By comparing interlay versus underlay techniques, the study aims to identify which method provides better results for patients. The findings may help refine surgical approaches and improve the overall quality of life for individuals undergoing tympanoplasty.

Conditions

Chronic Otitis Media; Tympanic Membrane Perforation; Conductive Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Underlay Technique)

Patients will undergo tympanoplasty using the underlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated, and the temporalis fascia graft will be placed beneath the remaining tympanic membrane layers along the annulus. The flap will then be repositioned, and the external auditory canal will be packed.

Group Type: EXPERIMENTAL

Underlay Tympanoplasty

Intervention Type: PROCEDURE

Tympanoplasty performed using the underlay graft technique, where the graft is positioned beneath all three layers of the tympanic membrane remnant.

Group B (Interlay Technique)

Patients will undergo tympanoplasty using the interlay graft technique. Under endoscopic guidance, the tympanomeatal flap will be elevated circumferentially. The temporalis fascia graft will be inserted between the fibrous and mucosal layers of the tympanic membrane, particularly beneath the handle of the malleus, before repositioning the flap.

Group Type: EXPERIMENTAL

Interlay Tympanoplasty

Intervention Type: PROCEDURE

Tympanoplasty performed using the interlay graft technique, where the graft is positioned between the mucosal and fibrous layers of the tympanic membrane.

Interventions

Underlay Tympanoplasty

Tympanoplasty performed using the underlay graft technique, where the graft is positioned beneath all three layers of the tympanic membrane remnant.

Intervention Type: PROCEDURE

Interlay Tympanoplasty

Tympanoplasty performed using the interlay graft technique, where the graft is positioned between the mucosal and fibrous layers of the tympanic membrane.

Intervention Type: PROCEDURE

Other Intervention Names

Underlay Graft Placement; Interlay Graft Placement

Eligibility Criteria

Inclusion Criteria

• Patients aged l6-60 years, of any gender.
• individuals with chronic otitis media characterized by inactive mucosal disease (absence of discharge) accompanied by a large central perforation persisting for at least 6 weeks and exhibiting pure conductive hearing loss as established through pure-tone audiometry.

Exclusion Criteria

• Presence of active otitis media manifesting acute infection or discharge.
• Patients diagnosed with tympanosclerosis or ossicular necrosis, adversely affecting ossicular chain mobility, as identified in preoperative assessments.
• History of ear surgeries, excluding myringotomy, that could potentially impact tympanoplasty outcomes, such as ossiculoplasty or mastoidectomy.
• Individuals with sensorineural or mixed hearing loss, as determined by pure-tone audiometry, indicating a possible alternate or additional source of hearing impairment.
• Conditions potentially hindering wound healing or compliance with postoperative care, including but not limited to uncontrolled diabetes mellitus or immunodeficiency disorders.
• Patients exhibiting eustachian tube dysfunction, as confirmed through clinical evaluation or medical records.
• Patients with an active focus of infection in the throat, nose, paranasal sinuses, or oral cavity, as determined by medical records.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaikh Zayed Hospital, Lahore

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Israr

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shaikh Zayed Medical college/hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

ShaikhZayedH1

Identifier Type: -

Identifier Source: org_study_id