There are different methods in the world for cochlear implantation such as( cochleostomy or round window) in children with auditory problems. Each method improve patient’s speech or hearing abilities vie specific mechanism. There are a lot of experimental or clinical trial studies about the role of different methods on children’s speech or hearing abilities while there’s not enough evidences in comparison of these methods together. The goal of this study is comparing the effect of two surgical methods of cochlear implantation on patient’s function after surgery
This study is a clinical trial that is designed to comparison the results of cochleostomy and round window methods during 2015 till 2016. All patients who are candidate for cochlear implantation in Pediatric Hospital of Tabriz, take part in this study. All participants randomly divided in two groups. The first group composed of patients under cochleostomy surgery while patients in second group will undergo round window surgery.
All patients will be examined by two types of test after surgery. First is speech intelligibility rating test and the other is Categories of Auditory Performance test. All patient’s information will be recorded and compare between two groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121531429N1
Registration date:2017-01-31, 1395/11/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-31, 1395/11/12
Registrant information
Name
Yalda Jabbarimoghadam
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 161 3913
Email address
jabbariy@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative results of cochlear implantation with round window and cochleostomy approach in patients undergoing cochlear implant
Public title
Comparison of postoperative results of cochlear implantation with round window and cochleostomy approach in patients undergoing cochlear implant
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients which are candidate for cochlear implant; patients admitted to Pediatric Hospital of Tabriz
exclusion criteria: patients with post surgery complications; coexisting diseases affected on auditory system.
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
all patients who are cochlear implantation surgery, will be divided randomly in two study groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences, Faculty of Medicine, Department of Otolar
Street address
Tabriz University of Medical Science, Daneshgah avenue, Tabriz,East Azerbaijan
City
Tabriz
Postal code
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.TBZMED.REC.1395.2.25
Health conditions studied
1
Description of health condition studied
cochlear implantation
ICD-10 code
H80,H83
ICD-10 code description
Other specified diseases of inner ear
Primary outcomes
1
Description
Speech Intelligibility
Timepoint
45-60 days after surgery then very three months to one year
Method of measurement
Speech Intelligibility Rating
2
Description
Auditory Performance
Timepoint
45-60 days after surgery then very three months to one year
Method of measurement
Categories of Auditory Performance
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1: surgery with Cochleostomy
Category
Treatment - Surgery
2
Description
intervention group 2: surgery by Round Window method
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Dr.Masood Naderpour
Street address
Tabriz Children's Hospital, Sheshgelan street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Masood Naderpour
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz 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
Department of Otolaryngology of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Masood Naderpour
Position
phd/professor
Other areas of specialty/work
Street address
Department of Otolaryngology, Imam Reza Hospital, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 2076
Fax
Email
info@imamreza.tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Otolaryngology, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Masood Naderpour
Position
PHD.
Other areas of specialty/work
Street address
Department Otolaryngology, Imam Reza hospital, Golgasht street, Tabriz
City
Tabri
Postal code
Phone
+98 41 3335 2076
Fax
Email
info@imamreza.tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Zohreh Amini
Position
Medical Doctor
Other areas of specialty/work
Street address
Department Otolaryngology, Imam Reza hospital, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)