Comparison of Surgical Outcomes of Endoscopic and Microscopic Surgery in Patients diagnosed as Otosclerosis Disease (Success of surgery, Duration of surgery, Complications)
Design
Two arm parallel group randomised clinical trial design of 62 patients; with method of Foursquare blocks, with out blinded outcome assessment.
Settings and conduct
In this study, Patients who are diagnosed as Otosclerosis Disease in Imam Khomeini Hospital between 2020 to 2021 are divided randomly into two groups. One group undergo Endoscopic surgery and the other group undergo Microscopic surgery.
Participants/Inclusion and exclusion criteria
Entry Requirements: Patients with a possible diagnosis of Otosclerosis
Exit Conditions: History of previous Otologic Surgery-External Auditory Canal Stenosis below 8 mm
Intervention groups
First Group: Patients who have surgery through Endoscope.
Eecond Group: Patients who have surgery through Microscope.
Main outcome variables
Endoscopic Otosclerosis Surgery has a higher success rate and fewer complications than the Microscopic method.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171004036554N3
Registration date:2021-01-06, 1399/10/17
Registration timing:registered_while_recruiting
Last update:2021-01-06, 1399/10/17
Update count:0
Registration date
2021-01-06, 1399/10/17
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
2020-11-09, 1399/08/19
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Surgical Outcomes of Endoscopic and Microscopic Surgery in Patients diagnosed as Otosclerosis Disease
Public title
Comparison of Surgical Outcomes of Endoscopic and Microscopic Surgery in Patients diagnosed as Otosclerosis Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patiants diagnosed as Otosclerosis Disease
Exclusion criteria:
History of previous Otologic Surgery
Revision Surgery for Otosclerosis
External Auditory Canal Stenosis below 8 mm
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization type is blocked randomization. Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope. Then cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence.
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
Vice Chancellor for Research and Technology, Keshavarz Boulevard Ghods St, Medical University of Tehran,
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1399.021
Health conditions studied
1
Description of health condition studied
Otosclerosis Disease
ICD-10 code
H80
ICD-10 code description
Otosclerosis Disease
Primary outcomes
1
Description
Audiologic Outcomes
Timepoint
Hearing Level at the beginning of the study and 2 months after surgery
Method of measurement
Audiology Test
2
Description
Post Operation Vertigo
Timepoint
First day after surgery
Method of measurement
VAS Test
3
Description
Post Operation Taste Disorder
Timepoint
2 months after surgery
Method of measurement
VAS Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: In this group surgery is performed using an Endoscope device that includes an Endoscopic Camera and Lens, through the Auditory Canal.
Category
Treatment - Surgery
2
Description
Control Group: In this group surgery is performed using a Surgical Microscope. This procedure usually requires an incision behind the ear for better access during surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Hamed Emami
Street address
Imam Khomeini Hospital, Dr.Qarib St, Kheshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2393
Email
hd-emami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeian Mohammad Ali
Street address
corner of Quds Street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 3698 8163
Email
resdeputy@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
Dr Yasaman Nemati
Position
Otolaryngologists, Resident at Tehran University of Medical Sciences
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini Hospital Complex, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2393
Fax
Email
yasaman.nemati90@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
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 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
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 6119 2393
Fax
Email
h_emami@sina.tums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
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