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. This is a double blind randomized clinical study in a single center (Dastghaib Hospital Shiraz -Iran). Both of them audiologist who measures hearing outcome and statistician who analyzes data will be blinded. Patients divide in two groups: in the first group, 50 patients will be undergone ossicular reconstruction with titanium prosthesis and in the second group 50 patients will be undergone ossicular reconstruction with Polycel prosthesis. According to our centre routine approach, the surgery is performed in two stages: the first stage includes cleaning the middle ear from possible pathologies and tympanic membrane repair and the second stage includes ossicular reconstruction surgery. Thus, all patients requiring ossicular reconstruction surgery in the second stage surgery will be included in the study. Patients with sensorineural hearing loss and who have inadequate follow-up will be excluded. Six months after operation, primary outcome (hearing improvement) will be evaluated with pure tone audiometry tests and the two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082815496N19
Registration date:2016-01-21, 1394/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-21, 1394/11/01
Registrant information
Name
Sareh Roosta
Name of organization / entity
Vice Chancellor for Research and Technology, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5323
Email address
namazi_balini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-06-21, 1392/03/31
Expected recruitment end date
2015-12-21, 1394/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison hearing results in patients with Partial Ossicular Replacement Prosthesis(PORP) titanium versus Polycel
Public title
Comparison of Hearing results after ossiculoplasty: titanium versus Polycel
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:All patients who referred due to ossicular chain reconstruction in the second stage of operation.
Exclusion criteria: presence of cholesteatoma, granulation tissue in second look and tympanic membrane perforation; patients with sensorineural hearing loss; inadequate follow-up after surgery (less than 6 months)
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)
Double blinded
Blinding description
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 Street
City
Shiraz
Postal code
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
IR.sums.med.rec.1394.s49
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 threshold
Timepoint
before operation -6 months after operation
Method of measurement
pure tone audiometry
Secondary outcomes
empty
Intervention groups
1
Description
ossicular chain reconstruction with Polycell prosthesis in control group
Category
Treatment - Surgery
2
Description
ossicular chain reconstruction with titanium prosthesis in intervention group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Dastgheib Hospital
Full name of responsible person
Dr. Mohammad Faramarzi
Street address
Hafez Street, Next to National Garden
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
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, Shiraz 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, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Khalil Tale
Position
ENT resident
Other areas of specialty/work
Street address
Department of Otolaryngology, Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3629 1478
Fax
Email
masihtale@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Otolaryngology, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Faramarzi
Position
Associate Professor of Otolaryngology
Other areas of specialty/work
Street address
Department of Otolaryngology,Khalili Hospital, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3629 1478
Fax
Email
Faramarzi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Center for Development of Clinical Studies of Nemazee Hospital, Vice Chancellor of Research and Tech
Full name of responsible person
Sareh Roosta
Position
MSc of Biostatistics
Other areas of specialty/work
Street address
Center for Development of Clinical Research of Nemazee Hospital, Nemazee Square
City
Shiraz
Postal code
Phone
+98 71 3612 5323
Fax
Email
Roosta.Sareh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)