Comparison of "intratympanic dexamethasone" with "Round Window Gelfoam and Middle Ear Injection of Methylprednisolone" in sudden sensorineural hearing loss
This study is a clinical trial study conducted at Al- Zahra and Ayatollah Kashani hospitals of Isfahan in 2012band 2013. The patients who entered in to the study were randomly assigned in two groups. In the first group sedation was used to lift up the ear flap through Transcanal method, then a Gelfoam soaked with methylprednisolone was placed on the site of Round Window and Gelfoam was placed on it. The second group of patients have intratympanic injection over the round window and received 3 doses of 0.5 cc dexamethasone with two days interval. After one month, patients in both groups are again assessed, and before and after intervention audiometries are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211062106N5
Registration date:2014-10-15, 1393/07/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-10-15, 1393/07/23
Registrant information
Name
Afrooz Eshaghian
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7247
Email address
eshaghian@edc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-12-31, 1391/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "intratympanic dexamethasone" with "Round Window Gelfoam and Middle Ear Injection of Methylprednisolone" in sudden sensorineural hearing loss
Public title
The comparative study of the effect of Intratympanic dexamethasone and dexamathasone in gelfom after myringotomy in sudeen sensory neural hearing loss in Kashani and Al-zahra hospital in 2012-2013
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients with SSNHL who referred to the Al- Zahra and Ayatollah Kashani hospitals of Isfahan; no improvement in SSNHL with conventional treatments and systemic steroids; no pregnancy; no organ transplantation and patient satisfaction to participate in the study.
Exclusion criteria: patients who failed to follow-up one month after treatment and the ones on whom it was not possible to apply the treatment
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences , Hezarjarib St.
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
444-14
Health conditions studied
1
Description of health condition studied
Hearing
ICD-10 code
H83.9
ICD-10 code description
Disease of inner ear, unspecified
Primary outcomes
1
Description
Hearing
Timepoint
Before intervention and one month after intervention
Method of measurement
Pure Tone Audiometry
Secondary outcomes
1
Description
Complication
Timepoint
During study
Method of measurement
Questioning about complication
Intervention groups
1
Description
Round Window Gelfoam and Middle Ear Injection of Methylprednisolone
Category
Treatment - Surgery
2
Description
intratympanic dexamethasone
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra medical center
Full name of responsible person
Street address
City
Isfahan
2
Recruitment center
Name of recruitment center
Kashani medical center
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Scinces, Vice challenry
Full name of responsible person
Peyman Adibi
Street address
Isfahan University of Medical Sciences , Hezarjarib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Scinces, Vice challenry
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
Isfahan University of Medical Scinces
Full name of responsible person
Abbas Nadalinejhad
Position
Resident of ENT
Other areas of specialty/work
Street address
Otolaryngology ward, Alzahra hospital, Sofe st.
City
Isfahan
Postal code
Phone
+98 31 3668 2525
Fax
Email
nadali.abbas@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical sciences
Full name of responsible person
Abbas Nadalinejhad
Position
Resident
Other areas of specialty/work
Street address
Otolaryngology ward, Alzahra hospital, Sofe st.
City
Isfahan
Postal code
Phone
+98 31 3668 2525
Fax
Email
nadali.abbas@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Afrooz Eshaghian
Position
resident
Other areas of specialty/work
Street address
Otolaryngology ward, Alzahra hospital, Sofe st.
City
Isfahan
Postal code
Phone
+98 31 3625 5555
Fax
Email
afroozeshaghian@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)