Comparison of hearing outcome between incus inposition and angular clip titanium prosthesis in patients with I-S joint erosion because chronic otitis media in 2015 to 2017 in Imam Khomeini
Chronic otitis media is a prevalent disease which can cause damage to the ossicles and consequently conductive hearing reduction. An effective surgical method that can eliminate chronic infection, as well as improving the hearing ability is a geat concern for otolaryngologists. The aim of this study is to compare incus inposition surgery with reconstruction with angular clip prosthesis and to determine which method can provide a better hearing outcome for patients.
Patients with chronic otitis media who suffered from incus erosion and underwent Incus Inposion surgery using Incus autograft and tympanoplasty are included in this interventional study. Patients who underwent revision surgery, are in need of TROP prosthesis installment, their stapes bone is immobile and experienced graft failure are excluded from this study. This study consists of two groups, the first group includes 25 patients who underwent Incus Inposition surgery. The second group includes same number of patients who will go through reconstruction with angular clip prosthesis and tympanoplasty. Data from pre-operative and post-operative audiometry exam will be analyzed. Air bone gap and Bone conduction threshold will be calculated for each patient and the mean of Air bone gap and Bone conduction threshold will be determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101136554N2
Registration date:2017-10-28, 1396/08/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-28, 1396/08/06
Registrant information
Name
Hamed Emami
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2393
Email address
h_emami@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hearing outcome between incus inposition and angular clip titanium prosthesis in patients with I-S joint erosion because chronic otitis media in 2015 to 2017 in Imam Khomeini
Public title
Comparison of two surgical methods in improvement of hearing among patients with chronic ear infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with I-S joint erosion because of chronic otitis media.
Exclusion criteria : patients who underwent revision surgery ; patients who need TORP Prosthesis installment ; patients with immobile stapes bone ; patients with graft failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1673
Health conditions studied
1
Description of health condition studied
I-S joint erosion because of chronic otitis media
ICD-10 code
H74.2
ICD-10 code description
Discontinuity and dislocation of ear ossicles
Primary outcomes
1
Description
air bone gap
Timepoint
6 month
Method of measurement
audiometry
2
Description
Bone conduction treshold
Timepoint
6 months
Method of measurement
audiometry
Secondary outcomes
empty
Intervention groups
1
Description
reconstruction with angular clip prosthesis
Category
Treatment - Surgery
2
Description
incus inposition
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hostpital
Full name of responsible person
Dr Hamed Emami
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Science and Technology of Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yoonesian
Street address
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz blvd. and Qods St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Science and Technology of 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
Tehran University of Medical Sciences
Full name of responsible person
Fateme Shoja Sefat
Position
Resident of Otolaryngology
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6658 1628
Fax
Email
fatemeshojasefat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Emami
Position
Otolaryngologists, Assistant professor at Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2393
Fax
Email
h_emami@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Hamed Emami
Position
Otolaryngologists, Assistant professor at Tehran University of Medical Sciences
Other areas of specialty/work
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2393
Fax
Email
hd_emami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)