Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000436471
Ethics application status
Approved
Date submitted
8/01/2025
Date registered
9/05/2025
Date last updated
9/05/2025
Date data sharing statement initially provided
9/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tympanoplasty Outcomes and Quality of life: Exploring Success, Failure, and Predictive Factors in adults with dry perforation
Scientific title
Tympanoplasty Outcomes and Quality of life: Exploring Success, Failure, and Predictive Factors in adults with dry perforation
Secondary ID [1] 313651 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic otitis media 336221 0
Condition category
Condition code
Ear 332754 332754 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All surgeries were performed using the postauricular approach under general anesthesia. The procedure involved harvesting temporalis fascia or conchal cartilage, refreshing the edges of the perforation and the medial surface of the tympanic membrane, elevating the meatal flap and annulus, and preparing the middle ear space. Ossicular reconstruction, when required, was carried out using cartilage grafts, incus interposition, or partial ossicular replacement prostheses (PORPs). The underlay grafting technique was employed in all cases. The Eustachian tube and tympanic cavity were packed with gelfoam to support graft placement. Patients were administered acetaminophen as needed and were observed in a day-surgery unit for approximately 24 hours postoperatively. All surgeries were performed by senior otolaryngology residents under the supervision of ENT and otologic surgeons. The anticipated duration of each procedure was approximately 2 hours.
Intervention code [1] 330250 0
Treatment: Surgery
Comparator / control treatment
control participants have dry perforation but did not undergo tympanoplasty.
Control group
Active

Outcomes
Primary outcome [1] 340286 0
Quality of life
Timepoint [1] 340286 0
Baseline (before surgery) and after 3 months (primary timepoint) and 6 months for participants undergoing tympanoplasty procedure. Baseline and after 3 months for controls.
Primary outcome [2] 340448 0
Depression and Anxiety
Timepoint [2] 340448 0
Baseline (before surgery) and after 3 months (primary timepoint) and 6 months for participants undergoing tympanoplasty procedure. Baseline and after 3 months for controls.
Secondary outcome [1] 443622 0
Hearing thresholds
Timepoint [1] 443622 0
Baseline (before surgery) and after 3 and 6 months for participants undergoing tympanoplasty procedure. Baseline and after 3 months for controls.

Eligibility
Key inclusion criteria
Participants with dry perforation aged between 18-55 years old
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients younger than 18 years old, who had active squamous chronic otitis media (cholesteatoma), acute perforation, severe uncontrolled chronic disease, using hearing aids, physical disability, psychiatric medications, and pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2024
Date of last participant enrolment
Anticipated
Actual
16/06/2024
Date of last data collection
Anticipated
Actual
19/12/2024
Sample size
Target
78
Accrual to date
Final
111
Recruitment outside Australia
Country [1] 26806 0
Syrian Arab Republic
State/province [1] 26806 0

Funding & Sponsors
Funding source category [1] 318118 0
Self funded/Unfunded
Name [1] 318118 0
this study is genuinely unfunded
Country [1] 318118 0
Primary sponsor type
University
Name
Damascus University
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 320497 0
Hospital
Name [1] 320497 0
Al Mouwasat University Hospital
Address [1] 320497 0
Country [1] 320497 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316763 0
Damascus University
Ethics committee address [1] 316763 0
Ethics committee country [1] 316763 0
Syrian Arab Republic
Date submitted for ethics approval [1] 316763 0
01/07/2023
Approval date [1] 316763 0
04/10/2023
Ethics approval number [1] 316763 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138938 0
Dr Adel Azar
Address 138938 0
Al Mouasat University Hospital, G767+R8X, Omar Bin Abdulaziz, Damascus, Syria
Country 138938 0
Syrian Arab Republic
Phone 138938 0
+963994083081
Fax 138938 0
Email 138938 0
[email protected]
Contact person for public queries
Name 138939 0
Adel Azar
Address 138939 0
Al Mouasat University Hospital, G767+R8X, Omar Bin Abdulaziz, Damascus, Syria
Country 138939 0
Syrian Arab Republic
Phone 138939 0
+963994083081
Fax 138939 0
Email 138939 0
[email protected]
Contact person for scientific queries
Name 138940 0
Adel Azar
Address 138940 0
Al Mouasat University Hospital, G767+R8X, Omar Bin Abdulaziz, Damascus, Syria
Country 138940 0
Syrian Arab Republic
Phone 138940 0
+963994083081
Fax 138940 0
Email 138940 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator
a method of contact: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.