NCT07149480

Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Shaikh Zayed Hospital, Lahore · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2025-01-09
• Primary completion: 2025-07-09
• Completion: 2025-07-09
• First posted: 2025-09-02
• Last updated: 2025-09-02

Locations

1 site across 1 country: Pakistan