The aim of this study is to evaluate the effect of cartilaginous and bony hump removal on final aesthetic dorsal line after rhinoplasty.
Design
40 patients with nasal deformity attending Ear, Nose & Throat clinic of Imam Khomeini hospital that fulfill the inclusion criteria will be selected for this study.
Settings and conduct
This study is conducted in the ٍENT department of Imam Khomeini hospital.
All eligible candidates are asked to complete 2 questionnaires (demographic and NOSE) , preoperative and postoperative standard photography are analyzed with Image J program to evaluate the effect of estimated hump removal and intra-operative hump removal with the final dorsal aesthetic line and patients satisfaction based on ROE questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients at the age of 18 years old or higher with normal psychological background who can pay the surgical expenses are included.
Exclusion criteria: previous history of septoplasty or septorhinoplasty; severe deviated nose; craniofacial anomalies; cleft lip nose; severe facial trauma; saddle nose; pregnancy; immunodeficiency and follow-up duration less than 6 months
Intervention groups
The main intervention is hump (cartilaginous and bony ) removal in septorhinoplasty.
Main outcome variables
The main outcome of this study are patient's satisfaction and final nasal dorsal aesthetic line according to aesthetics assessments.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170130032287N2
Registration date:2018-01-17, 1396/10/27
Registration timing:registered_while_recruiting
Last update:2018-01-17, 1396/10/27
Update count:0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Amir Arvin Sazgar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
asazgar@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Science
Expected recruitment start date
2017-05-22, 1396/03/01
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
The effect of the amount of bony and cartilaginous hump removal on final dorsal aesthetic line after rhinoplasty
Public title
The effect of hump and bony reduction on final dorsal aesthetic line
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with the age of 18 or more
being mentally healthy (according to the questionnaire)
Financial ability to afford the cost of surgery
Exclusion criteria:
History of Septoplasty or septorhinoplasty
Severe deviated nose
Craniofacial anomalies
Cleft lip nose
History of severe traumas which have caused serious anatomical changes
Saddle nose
Pregnancy
Immunodeficiency
Duration of follow-up less than 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.TUMS.VCR.REC.1396.2203
Health conditions studied
1
Description of health condition studied
َAcquired Nasal deformity
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
2
Description of health condition studied
congenital nose deformity
ICD-10 code
Q30.9
ICD-10 code description
Congenital malformation of nose, unspecified
Primary outcomes
1
Description
Final nasal dorsal aesthetic line.
Timepoint
first, third, sixth and 12th months
Method of measurement
measurement of angles and distances of the face on standard photographs using Image J software
Secondary outcomes
1
Description
Patient's satisfaction of final result of rhinoplasty surgery
Patients will undergo septorhinoplasty with open approach. The bony and cartilaginous hump are removed separately after degloving of the skin and separation of bilateral upper lateral cartilages. The removed bony and cartilaginous parts are measured exactly.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr. Narges Mikaniki
Street address
Valiasr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1628
Email
nargesmikaniki@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Science
Full name of responsible person
Dr. Ali Sahraian
Street address
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
Vice chancellor for research, Tehran University of Medical Science
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 Narges Mikaniki
Position
Resident of Otolaryngology
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
Fax
Email
nargesmikaniki@gmail.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 Amir Arvin Sazgar
Position
Otolaryngologists
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
Fax
Email
entrc@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
Amir Arvin Sazgar
Position
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
Fax
+98 21 6658 1628
Email
asazgar@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
According to the written consent signed by the participants all data are confidential and not to be shared with others.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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