Tympanic Membrane PerforationNCT06257602
Microscopic Versus Endoscopic Tympanoplasty
An observational study of Tympanic Membrane Perforation, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Tragal graft tympanoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Mahmoud A Ragaai, MD contact
About this study
Official title: Tragal Cartilage Graft Tympanoplasty: Microscopic Versus Endoscopic
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:
- Graft uptake, hearing outcome, postoperative pain, and healing time.
- 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.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Tragal graft tympanoplasty
- Medical subject headings
- Tympanic Membrane Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tragal graft tympanoplastyProcedure or surgery
Also called Endoscopic tympanoplasty
Comparison study between Endoscopic and microscopic tympanoplasty using tragal graft
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tragal graft tympanoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tragal cartilage graft tympanoplasty: Microscopic versus endoscopic
Time taken during surgery in microscopic tympanoplasty versus time taken during endoscopic tympanoplasty in minutes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tympanic Membrane PerforationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Tharwat Fahmi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257602
- Sponsor's protocol ID
- Endoscopic tympanoplasty
- Status last verified
- Feb 2024
- First submitted
- 7 Dec 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tragal Cartilage Graft Tympanoplasty: Microscopic Versus Endoscopic
- ClinicalTrials.gov ID
- NCT06257602
- Acronym / sponsor ID
- Endoscopic tympanoplasty
- Conditions
- Tympanic Membrane Perforation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Graft uptake, hearing outcome, postoperative pain, and healing time.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic tympanoplasty group | – | Procedure: Tragal graft tympanoplastyEndoscopc 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. |
| Microscopic tympanoplasty group | – | Procedure: Tragal graft tympanoplastyMicroscopic tympanoplasty group: operating microscope and microscopic instruments will be used, and using tragal graft to reconstruct tympanic membrane perforations. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tragal graft tympanoplastyAlso: Endoscopic tympanoplastyComparison study between Endoscopic and microscopic tympanoplasty using tragal graft | Procedure or surgery | Endoscopic tympanoplasty group, Microscopic tympanoplasty group |
Primary outcome
Tragal cartilage graft tympanoplasty: Microscopic versus endoscopic
Time frame: 24 months
Time taken during surgery in microscopic tympanoplasty versus time taken during endoscopic tympanoplasty in minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 2085261Thomassin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud A Ragaai, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Tympanic Membrane Perforation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rania T Fahmi, Physcian (01203211138, ranoo4tharwt93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tragal cartilage graft tympanoplasty: Microscopic versus endoscopic (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.