Ossicular reconstruction in patients with chronic otitis media have contributed significantly to the improvement of their hearing and because of the variety of prostheses, so we decided to compare Hearing improvement after ossiculoplastic surgery between the two prostheses made of polycel and titanium.
The study design was a randomized single-blind and patient groups are sharing. In the first group, 50 patients underwent ossicular reconstruction with titanium prosthesis and in second group 50 patient with polycel prosthesis.
All patients who have conductive hearing loss due to chronic ear infections participated in the study and patients with sensorineural hearing loss and who have irregular follow-up are excluded.
In all selected patients total ossicular reconstruction surgery are performed And 1 month and 6 months after the operation result ( improved hearing) are evaluated with pure tone audiometry tests and compared the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205049631N1
Registration date:2013-08-23, 1392/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-23, 1392/06/01
Registrant information
Name
Reza Jahangiri
Name of organization / entity
Shiraz university of medical scences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6643
Email address
rjahangiri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hearing results in patients with Total Ossicular Replacement Prosthesis ( TORP) titanium versus Polycel in Shiraz Shahid Dastgheib hospital
Public title
Comparison of Hearing results after ossiculoplasty: titanium versus polycel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patients with chronic ottitis media and damage their ossicles and conductive hearing loss.
Exclusion criteria: presence of cholesteatoma in second look and large tympanic membrane perforation; inappropriate follow-up after surgery and patients with sensorineural hearing loss.
Age
From 15 years old to 70 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
ct-91-4317
Health conditions studied
1
Description of health condition studied
Chronic otitis media with ossicular disruption
ICD-10 code
H74.3
ICD-10 code description
Other acquired abnormalities of ear ossicles
Primary outcomes
1
Description
hearing results
Timepoint
before operation and 6 months after operation
Method of measurement
pure tone audiometry
Secondary outcomes
empty
Intervention groups
1
Description
ossicular reconstruction with polycell prostesis in control group
Category
Treatment - Surgery
2
Description
ossicular reconstruction with titanium prostesis in interventinal group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib hospital
Full name of responsible person
Faramarzi Abolhasan
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Hatam Gholam Reza
Street address
Zand street, Central bulding of Medical University
City
Shiraz
Grant name
طرح های پژوهشی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University of Medical Sciences
Full name of responsible person
Kabood Khani Reza
Position
ENTspecialis, head and neck flowship, Research Assistant
Other areas of specialty/work
Street address
khalili hospital, ENT department
City
Shiraz
Postal code
Phone
+98 71162944771
Fax
Email
kaboodkhani@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Faramarzi Abolhasan
Position
ENT specialist , otologic Fellowship
Other areas of specialty/work
Street address
Shiraz , khalili streat. ENT departmant
City
Shiraz
Postal code
Phone
+98 71162944771
Fax
Email
faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Jahangiri Reza
Position
ENT resident
Other areas of specialty/work
Street address
shiraz khalili street, ENT department
City
Shiraz
Postal code
Phone
+98 71 1629 4771
Fax
Email
rjahangiri@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)