MyringoplastyNCT06691139
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
An observational study of Myringoplasty, run by Mohamed Soltan Nada at 1 site in Egypt.
Trial summary
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myringoplasty
- What is being tested?
- Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years, Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft and Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jan 2024
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Sohag university hospital
Who may be able to join
- age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .
Who cannot join
- Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.
Trial locations and contacts
1 site in 1 country.
About this study
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
Read the detailed description
The aim of this clinical trials is to asses and compare the surgical outcomes of Temporalis fascia graft and periosteal graft in myringoplasty in terms of graft intake and audiological improvement
- Conditions
- Myringoplasty
- Being tested
- Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years, Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft, Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft, Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 yearsProcedure or surgery
Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia
Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graftOther
Group (A) Myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft
Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graftProcedure or surgery
Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft in age from 12years to 40 years
Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graftProcedure or surgery
Myringoplasty operation using Temporalis fascia graft and Myringoplasty using periosteal graft in patients from 12 years to 40 years
| Study group | Role | What they receive |
|---|---|---|
| Group (A) patients with periosteal graft | patients whose underwent to myringoplasty using periosteal graft Receives: Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years; Other: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft; Procedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft; Procedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft | |
| (B) patients with Temporalis fascia graft | patients whose underwent to myringoplasty using Temporalis fascia graft Receives: Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years; Other: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft; Procedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft; Procedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
hearing improvment
outcome of temporalis fascia graft and periosteal graft for managment tympanic membrane perforation for audiological improvement
Measured: from January 2022 to January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyringoplastyStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Soltan Nada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Soltan Nada, Sohag University
- Investigators
- ahmed Nada, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691139
- Sponsor's protocol ID
- Soh-med-15-10-11MS
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
- ClinicalTrials.gov ID
- NCT06691139
- Acronym / sponsor ID
- Soh-med-15-10-11MS
- Conditions
- Myringoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mohamed Soltan NadaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 15 Nov 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.
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
Detailed description
The aim of this clinical trials is to asses and compare the surgical outcomes of Temporalis fascia graft and periosteal graft in myringoplasty in terms of graft intake and audiological improvement
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) patients with periosteal graft | – | Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years, Other: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft, Procedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft, Procedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graftpatients whose underwent to myringoplasty using periosteal graft |
| (B) patients with Temporalis fascia graft | – | Procedure: Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 years, Other: Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft, Procedure: Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graft, Procedure: Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graftpatients whose underwent to myringoplasty using Temporalis fascia graft |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sohag university hospital
Key inclusion criteria (1 listed)
- age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .
Key exclusion criteria (1 listed)
- Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.
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 |
|---|---|---|
| Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia graft in patients ages from 12 years to 40 yearsMyringoplasty using periosteal graft and myringoplasty using Temporalis fascia | Procedure or surgery | (B) patients with Temporalis fascia graft, Group (A) patients with periosteal graft |
| Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graftGroup (A) Myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft | Other | (B) patients with Temporalis fascia graft, Group (A) patients with periosteal graft |
| Myringoplasty operation using periosteal graft and myringoplasty using Temporalis fascia graftMyringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft in age from 12years to 40 years | Procedure or surgery | (B) patients with Temporalis fascia graft, Group (A) patients with periosteal graft |
| Group (A) myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graftMyringoplasty operation using Temporalis fascia graft and Myringoplasty using periosteal graft in patients from 12 years to 40 years | Procedure or surgery | (B) patients with Temporalis fascia graft, Group (A) patients with periosteal graft |
Primary outcome
hearing improvment
Time frame: from January 2022 to January 2024
outcome of temporalis fascia graft and periosteal graft for managment tympanic membrane perforation for audiological improvement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- 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.
ahmed Nada principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myringoplasty, run by Mohamed Soltan Nada at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hearing improvment (time frame: from January 2022 to January 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.