The aim of this study is comparing the result of cartilage tympanoplasty using two packing materials : silastic sheet and gelfoam.
Design
78 patients will undergo cartilage tympanolpasty in Imam Khomeini hospital during 2017-2018. The surgeon will fill a questionnaire for each patients which contains demographic questions, symptoms and position of the tympanic membrane. then, patients will be divided into two groups (silastic sheet or gelfoam) using the random numbers table.
Settings and conduct
This study is conducted in the Valiasr hospital. Patients referred to Ear, Nose and Throat clinic will be separated into 2 groups if they meet the inclusion criteria. In our study, the patients, the surgeon (until the moment of surgery) and the statistician will be blind.
Participants/Inclusion and exclusion criteria
All patients who are candidate for COM unilateral cartilage tympanoplasty during the time of our study are included in the study. All patients will sign a written consent form.
Patients with history of sensory-neural hearing loss, history of anatomic disorders of auditory system, history of otorrhea in the last 3 months and patients who must undergo mastoidectomy are excluded from this study. All patients are free to leave the study and this will not affect the course of their treatment.
Intervention groups
There are 2 intervention groups in the current study. First group includes patients with perforated tympanic membrane who will undergo cartilage tympanoplasty using Gelfoam. Second group of these patients will undergo the same surgery using Silastic sheet.
Main outcome variables
The main outcome of this study is to evaluate the results of tympanoplasty by measuring the graft take, anatomic position of the graft and hearing improvement and comparing the outcomes in Gelfoam of silastic sheet groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171004036554N2
Registration date:2017-12-26, 1396/10/05
Registration timing:registered_while_recruiting
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
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
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the results of middle ear packing using Gelfom in comparison with silastic sheet in the treatment of timpanoplasty
Public title
Evaluation of the results of using two packing techniques in the repair of perforated tympanic membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are candidate of COM unilateral cartilage tympanoplasty
patients who volunteer to participate in this study
Exclusion criteria:
History of sensory-neural hearing loss
History of anatomic disorder of auditory system
Patients who must undergo mastoidectomy
Anterior perforation of TM
history of otorrhea in the last 3 months
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a randomized clinical trial which uses blocking technique. Each block block contains 4 patients, as a result 20 arrangements are possible. In selection of blocks, table of randomizes numbers is used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The surgeon is not informed of the surgical technique until the middle of surgery when the packing material is delivered to the surgical team. Evaluation of results and examination of patients is performed by a second surgeon 3 months after the surgery. Therefore the surgeon is blind to the technique until the moment of surgery. Statistician and the patients are also blind.
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
Central department of Tehran University of Medical Sciences, Intersection of Keshavarz blvd. and Qods St. , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4083
Health conditions studied
1
Description of health condition studied
Repairing techniques in perforated tympanic membrane
ICD-10 code
H72
ICD-10 code description
Perforation of tympanic membrane
Primary outcomes
1
Description
Graft take
Timepoint
3 months after the surgery
Method of measurement
physical examination using a microscope by the the surgeon
2
Description
Hearing improvemnt
Timepoint
3 month after the surgery
Method of measurement
Audiometry
3
Description
Anatomical position
Timepoint
3 months after the surgery
Method of measurement
physical examination using a microscope by the the surgeon
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Cartilage tympanoplasty using Gelfoam
Category
Treatment - Surgery
2
Description
Intervention group 2: Cartilage tympanoplasty using Silastic sheet
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr. Hamed Emami
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
entrc@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Ali Sahraian
Street address
Vice chancellor for research, Central department of Tehran University of Medical Sciences, Intersection of Keshavarz Blvd. and Qods St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
rmo@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ایلناز کاظمی
Position
Resident of otorhinolaryngology
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
elnazkazemi64@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ِDr. Hamed Emami
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
hd_emami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hamed Emami
Position
Assisstant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
hd_emami@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available