This study aimed to determine the positive and negative effects of corticosteroids on outcomes after Tympanoplasty surgery and applicable purpose of this study is preventing unnecessary prescribing steroids and reduction of complications .All 18-75 years patients with COM are enrolled and patients with vertigo before surgery, cholesteatoma ,previous ear surgery , active ear infections are excluded .All 20 patients ,randomly assigned to two groups; receiving and not receiving steroids ( dexamethasone 8 mg in 2 doses 12 hours apart ) after surgery . Other interventions such as surgery technique , taking steroid and antibiotic prophylaxis before surgery are the same in two groups and surgeons included from faculty will hold the skills in performing tympanoplasty .Then all study outcomes such as tinnitus, hearing loss ( BC thresholds) and graft status in month third after surgery are considered.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030510041N4
Registration date:2014-08-13, 1393/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-13, 1393/05/22
Registrant information
Name
Ali Kouhi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-kouhi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of steroid after tympanoplasty surgery on hearing level and bone conduction
Public title
Investigating the effect of steroid after tympanoplasty surgery on hearing level and bone conduction at valiasr & Amir Alam Hospitals in 2013-2014.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Age between18-75 years;Diagnosis COM
Exclusion criteria:Vertigo before surgery;Cholesteatoma;History of ear surgery;
Active infection; Complete tympanic perforation
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran university of Medical Sciences Building ,Keshavarz Blvd,Tehran ,Iran
City
Tehran
Postal code
Approval date
2014-02-26, 1392/12/07
Ethics committee reference number
106518-23363-48-03-92
Health conditions studied
1
Description of health condition studied
Otosclerosis
ICD-10 code
H80.9
ICD-10 code description
Otosclerosis, unspecified
Primary outcomes
1
Description
hearing assesment with bone conduction threshold
Timepoint
3 month after surgery
Method of measurement
audiometry
Secondary outcomes
1
Description
graft repair
Timepoint
after surgery
Method of measurement
examination
2
Description
tinnitus
Timepoint
after surgery
Method of measurement
examination
3
Description
vertigo
Timepoint
after surgery
Method of measurement
examination
Intervention groups
1
Description
Intervention group:two dose of 8 mg intratympanic injection Dexamethasone within 12 hours after surgery
Category
Treatment - Drugs
2
Description
Control group:
not receiving intratympanic injection of 8 mg of Dexamethasone within 12 hours after surgery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Alam Hospital
Full name of responsible person
Dr.Ali Kouhi
Street address
Saadi Ave,AmirAlam hospital ,Tehran,Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Valieasr Hospital
Full name of responsible person
Dr.Amin Amali
Street address
Bagher Khan Ave,Valieasr Hospital,Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr.masoud Yonesian
Street address
Keshavarz Blvd, Tehran,Iran
City
Tehran
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
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Otorhinolaryngology Research Center ,Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Kouhi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Saadi Ave. Amir alam Hospital, Tehran,Iran
City
Tehran
Postal code
Phone
+216 6760269
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Otorhinolaryngology Research Center Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Kouhi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Saadi Ave,Amir Alam Hospital, Tehran,Iran
City
Tehran
Postal code
Phone
+216 6760269
Fax
Email
a-kouhi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
AmirAlam Hospital
Full name of responsible person
Dr.Ali Kouhi
Position
Otolaryngologist
Other areas of specialty/work
Street address
Saadi ave,AmirAlam hospital,Tehran,Iran
City
Tehran
Postal code
Phone
+98 21 6676 0269
Fax
Email
A-kouhi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)