Crooked noses and very wide noses are one of the most severe forms of the nasal deformity and since many interpersonal relationships are done face-to-face daily, this deformity is very annoying for people who do not correct it irreversibly and can lead to decreased self-esteem. In this project, we investigate the effect of double lateral osteotomy on the correction of tilting of the lateral nasal walls and compare it with asymmetrical dorsal hump reduction.
Design
A double-blinded, parallel group randomised clinical trial
Settings and conduct
This study was performed in Taleghani Hospital, Tehran, Iran. After obtaining informed consent from patients, grouping them and storing information before and after intervention, data analysis was performed. Participants, health care providers, and analyzers of this study were blinded to the method used.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients with crooked nose.
Exclusion criteria include patients with S-shaped deformities of the nose, patients with facial asymmetrys and patients with nasal curvature due to cartilage structures.
Intervention groups
In one group double lateral osteotomy and in the other group an asymmetrical reduction of dorsal nasal height is used to correct nasal bending.
Main outcome variables
Nasal deviation correction, evaluation of deviation correction by each method, introduce a more effective method in correction of nasal deviation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200123046232N1
Registration date:2020-02-22, 1398/12/03
Registration timing:retrospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Sara Nouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 6231
Email address
nourisara@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Between Double Lateral Osteotomy and Asymmetric Dorsal Hump Reduction in Correction of Crooked Nose
Public title
Correction of Crooked Nose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Crooked Nose
Exclusion criteria:
S Shape Deformity of Nose
Facial Asymmetry
Cartilage Deformity
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method using random number tables.
The randomization unit is individual.
Allocation concealment through sealed opaque envelopes with random sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants in this study, clinical caregivers, outcome assessors, and data analysts were kept blind to the procedure performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No. 1, Shirin Dd End, North Mehrmohammadi St, Qeitarieh Blvd.
City
Tehran
Province
Tehran
Postal code
1934965131
Approval date
2019-08-05, 1398/05/14
Ethics committee reference number
IR.SBMU.MSP.REC.1398.427
Health conditions studied
1
Description of health condition studied
Crooked nose
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measurement of difference in degree of nasal deviation before and after surgery
Timepoint
Baseline (before intervention), 6 and 12 months after surgery
Method of measurement
Degree of nasal deviation using patient's photography
Taleghani Educational Hospital, ُShahid Erabi St., Daneshjou Blvd., Velenjak Region, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
http://taleghani.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Taleghani Educational Hospital, ُShahid Erabi St., Daneshjou Blvd., Velenjak Region, Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Nouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.1, Shirin Dead End, North Mehr Mohammadi St. , Andarzgou Blvd. , Qeitarieh, Tehran
City
Tehran
Province
Tehran
Postal code
1934965131
Phone
+98 21 2267 6231
Fax
Email
nourisara@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Nouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.1, Shirin Dead End, North Mehr Mohammadi St. , Andarzgou Blvd. , Qeitarieh, Tehran
City
Tehran
Province
Tehran
Postal code
1934965131
Phone
+98 21 2267 6231
Fax
Email
nourisara@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sara Nouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No.1, Shirin Dead End, North Mehr Mohammadi St. , Andarzgou Blvd. , Qeitarieh, Tehran
City
Tehran
Province
Tehran
Postal code
1934965131
Phone
+98 21 2267 6231
Fax
Email
nourisara@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data of participants is shared after being unidentified.
When the data will become available and for how long
Start of access period 12 months after releasing the results.
To whom data/document is available
It will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
In order to use the data to compare them with data of similar studies
From where data/document is obtainable
nourisara@sbmu.ac.ir
What processes are involved for a request to access data/document
After receiving the request and reviewing the applicant's information and ensuring that it is correct, within 1-2 weeks the information will be available to the applicant.