A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
November 13, 2024 updated by: Mohamed Soltan Nada
A Comparative Study of Temporalis Fascia Graft and Periosteal Graft in Myringoplasty
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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
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 Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Sohag, Egypt
- Sohag university hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Sohag university hospital
Description
Inclusion Criteria:
age 12years to 40 years Small to moderate sized perforation . Dry tubotympanic chronic suppurative otitis media For more than 6 weeks .
Exclusion Criteria:
Active discharge or superimposed otomycosis . Patients with sensorineural hearing loss. Patients with considerable nasal pathology.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group (A) patients with periosteal graft
patients whose underwent to myringoplasty using periosteal graft
|
Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia
Group (A) Myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft
Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft in age from 12years to 40 years
Myringoplasty operation using Temporalis fascia graft and Myringoplasty using periosteal graft in patients from 12 years to 40 years
|
|
(B) patients with Temporalis fascia graft
patients whose underwent to myringoplasty using Temporalis fascia graft
|
Myringoplasty using periosteal graft and myringoplasty using Temporalis fascia
Group (A) Myringoplasty using periosteal graft Group (B) Myringoplasty using Temporalis fascia graft
Myringoplasty using Temporalis fascia graft and myringoplasty using periosteal graft in age from 12years to 40 years
Myringoplasty operation using Temporalis fascia graft and Myringoplasty using periosteal graft in patients from 12 years to 40 years
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
from January 2022 to January 2024
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: ahmed Nada, Sohag University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
November 1, 2024
First Submitted That Met QC Criteria
November 13, 2024
First Posted (Actual)
November 15, 2024
Study Record Updates
Last Update Posted (Actual)
November 15, 2024
Last Update Submitted That Met QC Criteria
November 13, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- Soh-med-15-10-11MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.