In this study we aim to assess the success of stapedotomy on reduction of tinnitus in patients with otosclerosis.
Design
Non-randomized clinical trial on 19 patients
Settings and conduct
Otolaryngology department. Imam Khomeini hospital complex, Tehran
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients wit otosclerosis with more than 30 dB of air-bone gap in latest pure tone audiometry; Presence of tinnitus in the same ear
Exclusion criteria: History of surgery in the same ear, superior semicircular canal dehiscence, Meniere's disease
Intervention groups
Patients with otosclerosis with concomitant tinnitus
Main outcome variables
Tinnitus Score based on patient VAS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201021049093N1
Registration date:2020-11-04, 1399/08/14
Registration timing:registered_while_recruiting
Last update:2020-11-04, 1399/08/14
Update count:0
Registration date
2020-11-04, 1399/08/14
Registrant information
Name
Mehrdad Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
mehrdadj82@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-13, 1399/07/22
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Stapedotomy on Tinnitus in Patients with Otosclerosis
Public title
Effects of ear surgery on Tinnitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Otosclerosis with more than 30 dB of air-bone gap in pure tone audiometry
Tinnitus in the same ear
Exclusion criteria:
Previous surgery in the same ear
Superior semicircular canal dehiscence
Meniere's Disease
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
19
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Baqerkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
TUMS.AMIRALAM.REC.1399.010
Health conditions studied
1
Description of health condition studied
Otosclerosis
ICD-10 code
H80
ICD-10 code description
Otosclerosis
Primary outcomes
1
Description
Tinnitus score
Timepoint
Before and 6 months after intervention
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with conductive hearing loss with more than 30 dB air-bone gap and concomitant tinnitus will undergo Stapedotomy surgery to resolve the ossicular chain stiffness following otosclerosis. The surgery would be done under general anesthesia or sedation through an intracanal incision. A hole would be drilled in the stapedius footplate and a Teflon piston prosthesis would be inserted in place.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Mehrdad Jafari
Street address
Baqerkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
mehrdadj82@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akhondzadeh
Street address
Qods
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
research@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Jafari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Baqerkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
mehrdadj82@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Jafari
Position
َAssistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Baqerkhan
City
Tehran
Province
Tehran
Postal code
14197363141
Phone
+98 21 6658 1628
Email
mehrdadj82@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrdad Jafari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Baqerkhan
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
mehrdadj82@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be published after deleting the recongnition data.
When the data will become available and for how long
from 2020
To whom data/document is available
researchers of academic institutes
Under which criteria data/document could be used
To be used in meta-analysis
From where data/document is obtainable
Otorhinolaryngology research center of Tehran university of medical sciences
What processes are involved for a request to access data/document
An email must be sent to the research corresponding author.