Auditometry comparison in stapedotomy using sodium hyaluronate gel
Design
In this study, 100 patients with otosclerosis who are eligible for inclusion in the study are selected. Participants are randomly divided into intervention and control groups and each code is assigned to hide the intervention group of each participant.
Settings and conduct
Since the adoption of the proposal, autosclerosis patients who were candidates for the action of the stroke, were randomly divided into two groups of hyaluronic acid and control.The randomization method was Block Randomization. The procedure and anesthesia were the same in the two groups. surgeries were conducted in educational hospitals under supervision of Shiraz University of Medical Sciences. All the surgeries were performed by the performer. The assistant co-worker then collected the surgical and auditory information and delivered it to the statistician. The statistics did not know about the procedure.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
- All patients with conductive hearing loss due to otosclerosis.
- Age between 18 and 60 years
- Have at least six months tracking
- Exit criteria:
- Patients who have osteopedictosis.
- Other causes of conductive hearing loss requiring surgery on a tibia such as the Tympanic Sclerosis
- Age under 18 and over 60
- Incomplete follow up or less than six months
Intervention groups
The intervention group consisted of 50 patients with otosclerosis who had criteria for entry into the study. in this patients using sodium hyaluronate gel in stapedotomy. The control group also includes 50 patients with otosclerosis who have criteria for entering the study. in this patients using fatty tissue in stapedotomy
Main outcome variables
Stapadotomy by using sodium hyaluronate gel compared to fatty tissue improves auditory results. It also reduces the risk of sensory neural hearing loss following stapedotomy.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180106038248N1
Registration date:2018-01-19, 1396/10/29
Registration timing:retrospective
Last update:2018-01-19, 1396/10/29
Update count:0
Registration date
2018-01-19, 1396/10/29
Registrant information
Name
Mohammad Ali Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4332 8533
Email address
asadiali977@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
Comparison of Hearing Results in Stapedotomy in Patient With Otosclrosis With and Without Sodium Hyaluronic Gel.
Public title
Effectiveness of Sodium hyaluronic gel in improvement of hearing in patient with otosclrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiant with hearin loss due to otosclerosis
Age 18-60
Can be fallowed up for 6 month
Exclusion criteria:
Patient with stapedectomy.
Other cause of hearing loss in patient that need stapes surgery.
Age under 18 and over 60.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with one person and random numbers 0 to 9.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those who evaluate the outcome That is, the auditory unit and Safety Committee and Data Supervision The type of material used in practice is unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz university of medical sciences, zand blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.SUMS.MED.REC.1395.67
Health conditions studied
1
Description of health condition studied
Otosclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of auditory hearing before and after stapedotomy using sodium hyaluronate gel compared with adipose tissue
Timepoint
audiometery befor and 21 days after surgury
Method of measurement
Audiometery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consisted of 50 patients with otosclerosis who had criteria for entry into the study. in these patients, sodium hyaluronate gel is used in surgery. In this method, during operation, after the prosthesis is applied, about 0.5 cc gels of sodium hyaluronate is injected around the prosthesis to prevent peri-lymph fluid leakage.
Category
Treatment - Surgery
2
Description
Control group: The control group also includes 50 patients with otosclerosis who have criteria for entering the study. In this method, during operation, after the prosthesis is applied, adipose tissue is used around the prosthesis to prevent peri-lymph fluid leakage.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgheyb hospital
Full name of responsible person
Mohammad Faramarzi
Street address
Dastgheyb hospital, Hafez Ave
City
Shiraz
Province
Fars
Postal code
7378113111
Email
faramarzi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Moavenat pajooheshi
Street address
Shiraz university of medical sciences, zand blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 2559
Email
president@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Faramarzi
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Khalili hospital, Khalili Ave
City
Shiraz
Province
Fars
Postal code
14336 -8 7134
Phone
+98 71 3629 1478
Email
Faramarzi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Faramarzi
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Khalili hospital, khalili Ave
City
Shiraz
Province
Fars
Postal code
14336 71348
Phone
+98 71 3629 1470
Email
Faramarzi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Faramarzi
Position
Asistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Khalili hospital, khalili Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3629 1470
Email
Faramarzi@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD