Microscopic Versus Endoscopic Tympanoplasty

NCT ID: NCT06257602

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-30
• Study Completion Date: 2025-12-30

Brief Summary

In this study, The investigatirs will compare surgical and anatomical outcomes of endoscopic and microscopic tympanoplasty type 1(myringoplasty) using tragal perichondrum and cartilage, and conduct a post-treatment survey regarding:

1. Graft uptake, hearing outcome, postoperative pain, and healing time.

2. Assess the operation time.

Detailed Description

Tympanic membrane perforation repair or tympanoplasty is a successful technique and has been validated in numerous studies since Wullstein and Zollner first proposed it in 1952. Previously, the technique was performed with illumination and magnification under a microscope. It typically requires an extensive postauricular incision to get through the narrow and curved external auditory canal, especially in child, complex perforations. The exclusive transcanal endoscopic tympanoplasty technique emerged in the 1990s; it provides more direct and wider surgical viewing angle, and it largely reduces the necessity for a traumatic postauricular incision in difficult cases. It has been gaining ground rapidly in recent years. Although closure rates tympanoplasty surgery can reach 90% or more, higher failure rates are seen in children, larger perforations, chronic Eustachian tube dysfunction, and in bilateral cases. Postoperative improvement in hearing is closely related to the postoperative change in the tympanogram. Postoperative hearing results and tympanograms are mainly influenced by the mucosal condition of the Eustachian tube (ET) orifice. Relatively greater improvement in hearing is observed in the long-term follow- up. Different graft materials have been proposed over the years to improve surgical outcomes, the search for an ideal graft is a subject of continued discussion, as transcanal endoscopic approaches have been proposed for larger and more complex perforations once reserved for postauricular techniques. The temporalis fascia (TF) has been the most preferred graft material for conventional microscopic tympanoplasty via postauricular or endaural approaches; it has theadvantages of having a readily available and plentiful source, and though its durability has been challenged in recent years, it is still widely used. However, with the increasing popularity of transcanal endoscopic ear surgery (TEES), an increasing number of otologists have adopted this technique and switched to using the nearby tragal perichondrium/cartilage graft when the surgical route is changed. The tragus has a pivotal function in reconstruction in ear surgery, and it is limited in source; hence, harvest on an ad hoc basis may lead to donor insufficiency at ensuing surgeries. Moreover, the tragus constitutes the anterior cartilaginous skeleton of the EAM and plays a role in sound transmission; maintaining its integrity would benefit future hearing device applications.

Conditions

Tympanic Membrane Perforation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic tympanoplasty group

Endoscopc tympanoplasty group: rigid endoscope 3 mm diameter/14 cm long/0 angle of view will be used together with a high-definition camera head and monitor and using tragal graft to reconstruct perforations of tympanic membrane.

Tragal graft tympanoplasty

Intervention Type: PROCEDURE

Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft

Microscopic tympanoplasty group

Microscopic tympanoplasty group: operating microscope and microscopic instruments will be used, and using tragal graft to reconstruct tympanic membrane perforations.

Tragal graft tympanoplasty

Intervention Type: PROCEDURE

Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft

Interventions

Tragal graft tympanoplasty

Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopic tympanoplasty

Eligibility Criteria

Inclusion Criteria

• Inactive chronic tubotympanic otitis media (dry ear: no otorrhea without

medication for at least 1 month).

• Patients with age 15-45 years old in both sexes.
• Patients with pure conductive hearing loss. unhealed tympanic membrane perforation for >3 months.
• Patients who are willing to give consent for the study.

Exclusion Criteria

• Deeper lesions (Attico-antral disease, ossiculopathy, atelectasis, cholesteatoma, etc.), if suspected, on computed tomography scan.
• Patients below 15 years old, and more than 45 years old.
• Previous tympanoplasty, or other ear surgery.
• Sensori- neural hearing loss.
• Discharging ear.
• Narrow obvious narrowing of the EAC or syndromes that affect the middle ear (e.g., Down syndrome). 7) Comorbid systemic diseases like diabetes or any chronic specific infection.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Rania Tharwat Fahmi

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Rania T Fahmi, Physcian

Role: CONTACT

ranoo4tharwt93@gmail.com

01203211138

Mahmoud A Ragaai, MD

Role: CONTACT

+201123122933

References

Thomassin JM, Duchon-Doris JM, Emram B, Rud C, Conciatori J, Vilcoq P. [Endoscopic ear surgery. Initial evaluation]. Ann Otolaryngol Chir Cervicofac. 1990;107(8):564-70. French.

Reference Type: BACKGROUND

PMID: 2085261 (View on PubMed)

Other Identifiers

Endoscopic tympanoplasty

Identifier Type: -

Identifier Source: org_study_id