CompletedNot Applicable

Comparison of Postoperative Outcomes of Interlay vs Underlay Graft in Tympanoplasty

Pakistan60 participantsStarted 2025-01-09

Plain-language 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.

Who can participate

Age range

16 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared two different graft placement techniques — interlay versus underlay — in tympanoplasty for eardrum perforation; based on what was found, does one technique appear to offer better hearing improvement, and which would you recommend for my situation?
2Since this study focused on closing the air-bone gap as its main measure of success, what kind of hearing improvement would be realistic to expect for me specifically, given the size and location of my perforation?
3The trial is now completed — has the results data been published or presented anywhere, and can you walk me through what the findings showed about hearing outcomes for each technique?
4How do the two graft placement methods differ in terms of surgical complexity, recovery time, and risk of complications like re-perforation, and does one carry a meaningfully different risk profile that I should weigh?
5Would standard tympanoplasty using the technique your team already performs be a comparable option for me, or is there a reason to specifically seek out a surgeon who uses the interlay approach based on what this trial found?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Hearing Gain (Closure in Air-Bone Gap)

Timeframe: 3 months after surgery

Trial details

NCT IDNCT07149480

SponsorShaikh Zayed Hospital, Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-09

View on ClinicalTrials.gov More Chronic Otitis Media trials