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Not yet recruitingNCT06257602Updated Feb 14, 2024

Microscopic Versus Endoscopic Tympanoplasty

An observational study in Tympanic Membrane Perforation, sponsored by Assiut University. Not yet recruiting. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-02-14.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
15 Years to 45 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Tympanic Membrane Perforation
03

In context

Tympanic Membrane Perforation

45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

After fulfilling all inclusion and exclusion criteria all patients will be subjected to

  • Full history taking including:
  • Personal History.
  • Full medical history includes: onset, course, duration, last attack, amount, and color of otorrhea.
  • History of hearing loss, tinnitus, and vertigo.
  • History of previous ear surgery.
  • Nasal symptoms, and other otorhinology symptoms.
  • Full otorhinology examination:
  • Full otorhinology examination including:

    1. Otological assessment: Size, site, side of perforation, and any ear discharge or any abnormality of the external auditory canal.
    2. Hearing tests.
    3. Nasal examination.
  • Audiological evaluation: (before and after surgery):
  • Pure tone audiometry.
  • Impedance tympanogram.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Procedure: Tragal graft tympanoplasty

  • Microscopic tympanoplasty group

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

    Procedure: Tragal graft tympanoplasty

Interventions

  • ProcedureTragal graft tympanoplasty

    Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft

    Also known as: Endoscopic tympanoplasty

06

What researchers measure

Primary outcomes

  1. Tragal cartilage graft tympanoplasty: Microscopic versus endoscopic

    Time taken during surgery in microscopic tympanoplasty versus time taken during endoscopic tympanoplasty in minutes

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 2085261 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06257602
Lead sponsor
Assiut University
Responsible party
Rania Tharwat Fahmi (Director, Assiut University) — Principal investigator
First posted
Feb 14, 2024
Start date
Mar 30, 2024 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Feb 14, 2024

Study contacts

Rania T Fahmi, Physcian
Contact
ranoo4tharwt93@gmail.com
01203211138
Mahmoud A Ragaai, MD
Contact
+201123122933

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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