NCT06257602

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. 1.Graft uptake, hearing outcome, postoperative pain, and healing time.
  2. 2.Assess the operation time.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1.7 years

First QC Date

December 7, 2023

Last Update Submit

February 5, 2024

Conditions

Tympanic Membrane Perforation

Outcome Measures

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

    24 months

Study Arms (2)

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

Tragal graft tympanoplastyPROCEDURE

Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft

Also known as: Endoscopic tympanoplasty
Endoscopic tympanoplasty groupMicroscopic tympanoplasty group

Eligibility Criteria

Age15 Years - 45 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 2085261BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Central Study Contacts

Rania T Fahmi, Physcian

CONTACT

01203211138ranoo4tharwt93@gmail.com

Mahmoud A Ragaai, MD

CONTACT

+201123122933

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 7, 2023

First Posted

February 14, 2024

Study Start

March 30, 2024

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

February 14, 2024

Record last verified: 2024-02