The purpose of this study is comparison of the audiometric and histological results of crushed cartilage tympanoplasty wih non crushed cartilage tympanoplasty, in a randomized clinical trail.
Patients with the indication for cartilage tympanoplasty devide to two groups with randomized blocking method.we have 20 patients in each group.during the surgery we prepare cartilage graft from concha cavum, in the first group we crush the cartilage slightly and place it on the graft of fascia with the underlying method . In the second group (control) the cartilage places uncrushed. For the patients with the indicatin of ossiculoplasty at this step we do typanoplasty and the ossicle reconstruction operates 1 year later.the patients will be examined and do audiometric tests every 4 months for 1 year. we will prepare biopsy from the cartilage graft Patients with the indication of ossiculoplasty(1 year later).it will be investigate for the features like chondrocytes viability and the connective tissue features.
inclusion criteria:
patints with the indication of cartilage tympanoplasty
there is not any age and sex limitations
at least 1 year follow up
exclusion criteria:
previous canal wall down (CWD)
revision surgery
history of chondritis (polychondritis &...)
patients with adhesive otitis
conductive and sensoryneural hearing threshold, the tympanic membrane condition and the cartilage graft will be studied and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017013132069N3
Registration date:2017-06-01, 1396/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-01, 1396/03/11
Registrant information
Name
Ardavan Tajdini
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 3037
Email address
a-tajdini@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Dr Yunesian, Vice chancellor for research, Tehran University of Medical Sciences, The Central Department, 6th floor, Qods st, Keshavarz blv, tel: 00982188987381-2www.tums.ac.ir/research, email:resdeputy@tums.ac.ir
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of audiometric and histologic results in crushed carilage tympanoplasty and non crushed :a Randomized clinical trial study
Public title
Results of using crushed cartilage in tympanoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
there is not any age and sex limitations
patints with the indication of cartilage tympanoplasty
at least 1 year follow up
exclusion criteria:
previous canal wall down (CWD)
revision surgery
history of chondritis (polychondritis &...)
patients with adhesive otitis
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)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Tehran University of Medical Sciences
Street address
Central Department Of University, 6th floor, Keshavarz blv, Qods st-
City
Tehran
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1550
Health conditions studied
1
Description of health condition studied
Chronic perforation of tympanic membrane
ICD-10 code
H72
ICD-10 code description
perforation of ear drum: persistent post-traumatic postinflammatory
Primary outcomes
1
Description
audiometric condition
Timepoint
before the surgery, every 4 months after surgery upto 1 year
Method of measurement
audiometric test and determin the hearing treshold in different frequencies
2
Description
tympanic mambrane condition
Timepoint
before the surgery, every 4 months after surgery upto 1 year
Method of measurement
physical examination and tympanometry
Secondary outcomes
1
Description
superior posterior tympanic retraction
Timepoint
1 year after surgery
Method of measurement
microscopic examination
2
Description
pars flaccida retraction
Timepoint
1 year after surgery
Method of measurement
microscopic examination
3
Description
sensoryneural hearing treshold
Timepoint
before the surgery and 1 year after surgery
Method of measurement
Audiometry
4
Description
conductive hearing treshold
Timepoint
before the surgery and 1 year after surgery
Method of measurement
audiometry (db)
5
Description
cartilage graft condition
Timepoint
1 year after surgery
Method of measurement
biopsy and staining
Intervention groups
1
Description
Intervention group : using crushed cartilage for tympanoplasty
Category
Treatment - Surgery
2
Description
Control group: non crushed cartilage tympanoplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Aalam Hospital
Full name of responsible person
Dr Nikou Hatami
Street address
Darvaze Dolat, Saadi st, Enqelqb st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Central Department of University, 6th floor, Qods st, Keshavarz blv
City
Tehran
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, 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 Science
Full name of responsible person
Dr Nikou Hatami
Position
ENT Resident
Other areas of specialty/work
Street address
Amir Alam Hospital, Darvaze Dolat, Saadi st, Enqelab st
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
nikouhatami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Science
Full name of responsible person
Dr Ardavan Tajdini
Position
ENT professor
Other areas of specialty/work
Street address
Darvaze Dolat, Saadi st, Engelab st
City
Tehran
Postal code
Phone
+98 21 6670 6106
Fax
Email
ardavan_taj@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Science, Amir Aalam Hospital
Full name of responsible person
Dr Nikou Hatami
Position
ENT Resident
Other areas of specialty/work
Street address
Darvaze Dolat, Enqelqb st, Saadi st-
City
Tehran
Postal code
Phone
Fax
Email
Nikouhatami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)