Tympanic Membrane PerforationNCT04687995
Tragal Perichondrium Versus Pretragal Fascial (SMAS) Graft for Endoscopic Myringoplasty
A study testing Endoscopic myringoplasty in people with Tympanic Membrane Perforation, run by Assiut University.
Trial summary
1. Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty. 2. Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Tympanic Membrane Perforation
- What is being tested?
- Endoscopic myringoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Nov 2022
- Phase
- Interventional
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Above 16 yrs old and less than 50 yrs old.
- Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).
- Dry ear: no otorrhea without medication for at least 1 month.
- Hearing loss gap not more than 50dB
Who cannot join
- Age less than 16 or more than 50.
- Discharging (active) central perforations.
- Unsafe CSOM with cholesteatoma.
- Suspected ossicular pathology in safe CSOM if the gap > 50dB.
- Previous ear surgery.
- Patients unfit for surgery or having chronic medical illness.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study
- Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.
- Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.
Read the detailed description
The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.
- Conditions
- Tympanic Membrane Perforation
- Being tested
- Endoscopic myringoplasty
- 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.
Endoscopic myringoplastyProcedure or surgery
Endoscopic myringoplasty by using two different grafts one each time
| Study group | Role | What they receive |
|---|---|---|
| Tragal preichondrium graft | Active comparator | Tragal perichodrium graft for endoscopic myringoplasty as a reference graft Receives: Procedure: Endoscopic myringoplasty |
| pretragal ( SMAS) fascia graft | Active comparator | pretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft Receives: Procedure: Endoscopic myringoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty
comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionNov 2022 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Gamal Noreldein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687995
- Sponsor's protocol ID
- Endoscopic myringoplasty
- Status last verified
- Nov 2020
- First submitted
- 26 Sep 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin MY, Chang TS, Liao JB. The Pretragal Superficial Musculoaponeurotic System Fascia: A New Graft Material for Transcanal Tympanoplasty. Otol Neurotol. 2020 Jun;41(5):644-653. doi: 10.1097/MAO.0000000000002599.
PubMed 32080032
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tragal Perichondrium Versus the Pretragal Fascial Grafts for Endoscopic Myringoplasty: Comparative Study
- ClinicalTrials.gov ID
- NCT04687995
- Acronym / sponsor ID
- Endoscopic myringoplasty
- Conditions
- Tympanic Membrane Perforation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Dec 2020 (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.
- Examine the treatment outcomes of the pretragal (SMAS) fascia as a new graft when used in endoscopic myringoplasty.
- Compare the results when using the tragal pericondrium as a graft in endoscopic myringoplasty regarding donor site and success.
Detailed description
The exclusive transcanal endoscopic tympanoplasty technique emerged in the1990s : it provides a more direct and wider surgical viewing angle, largely reduces the necessity for a traumatic postauricular incision. Some otolgists have adopted this technique using the nearby tragal perichondrium/cartilage graft. The tragus has a pivotal function in reconstruction in ear surgery. The superficial musculoaponeurotic system (SMAS) was first introduced by Mits and Peyroniein1976. It is located in the mid-face overlying the parotid gland and mimic muscles, It connects the dermis and the muscles, acting as a unique motor unit to produce facial expressions. The SMAS graft has great potential because it is accessible from the least invasive transcanal route of tympanoplasty, and is located away from the vital structures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tragal preichondrium graft | Active comparator | Procedure: Endoscopic myringoplastyTragal perichodrium graft for endoscopic myringoplasty as a reference graft |
| pretragal ( SMAS) fascia graft | Active comparator | Procedure: Endoscopic myringoplastypretragal ( SMAS) fascia graft for endoscopic myringoplasty as a new graft |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Above 16 yrs old and less than 50 yrs old.
- Clinically diagnosed central tympanic membrane perforations or chronic suppurative otitis media (tubo-tympanic).
- Dry ear: no otorrhea without medication for at least 1 month.
- Hearing loss gap not more than 50dB
Key exclusion criteria (6 listed)
- Age less than 16 or more than 50.
- Discharging (active) central perforations.
- Unsafe CSOM with cholesteatoma.
- Suspected ossicular pathology in safe CSOM if the gap > 50dB.
- Previous ear surgery.
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 |
|---|---|---|
| Endoscopic myringoplastyEndoscopic myringoplasty by using two different grafts one each time | Procedure or surgery | Tragal preichondrium graft, pretragal ( SMAS) fascia graft |
Primary outcome
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty
Time frame: Baseline
comparison of results when using tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty success rate by audiological evaluation by using audiotympanogram
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Background: PubMed 32080032Lin MY, Chang TS, Liao JB. The Pretragal Superficial Musculoaponeurotic System Fascia: A New Graft Material for Transcanal Tympanoplasty. Otol Neurotol. 2020 Jun;41(5):644-653. doi: 10.1097/MAO.0000000000002599.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic myringoplasty in people with 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 4 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 5 Jan 2021. 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 Hazem Gamal Noreldin, Resident (01024806122, hazzmnoreldin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of tragal perichondrium versus pretragal fascial (SMAS) graft for endoscopic myringoplasty (time frame: Baseline). 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 NCT04687995, 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 5 Jan 2021.