Comparison of lateral crura cut overly and medial crura cut overlay in creating and maintaining tip projection and rotation in Rhinoplasty patients: A nonrandomized single-blind trial
Comparison of lateral crural overlay and medial crural overlap technique in developement and maintenance of nasal tip projection and rotation in Rhinoplasty
Design
In this non-randomized single-blinded clinical trial, 48 patients were evaluated in two groups using Lateral crural overlay and Medial crural overlap Technique . Patients and person who measure outcomes were blind.
Settings and conduct
The standard photography before and after surgery (3 months and 12 months postoperation) was prepared and the nasal tip projection and rotation were determined via Photoshop software by Goode's method and nasolabial angle. The satisfaction rate from rhinoplasty and nasal function were assessed by Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) scale before, 3 months and 12 months after surgery
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with overprojected, droopy nose who were Rhinoplasty candidate
Exclusion criteria: history of nasal trauma, complex deformity of nose, deviated nose, cleft lip nose deformity, revision surgery
Intervention groups
Intervention group 1: using lateral crural overlay technique in rhinoplasty
Intervention group 2: using medial crural overlap technique in rhinoplasty
Main outcome variables
Nasal Tip Projection, Nasal Tip Rotation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080820001056N5
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
Registrant information
Name
babak saedi
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 0765
Email address
saedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-27, 1397/07/05
Expected recruitment end date
2018-12-31, 1397/10/10
Actual recruitment start date
2018-09-27, 1397/07/05
Actual recruitment end date
2018-12-31, 1397/10/10
Trial completion date
2020-01-05, 1398/10/15
Scientific title
Comparison of lateral crura cut overly and medial crura cut overlay in creating and maintaining tip projection and rotation in Rhinoplasty patients: A nonrandomized single-blind trial
Public title
Comparison of lateral crura cut overly and medial crura cut overlay in tip projection and rotation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for Rhinoplasty with overprojected nose
Patients candidate for Rhinoplasty with Droopy nose
Exclusion criteria:
Patients with history of nasal trauma
Patients with complex deformities, Deviated nose and, cleft lip- nose deformity
Revision Rhinoplasty
Age
From 16 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and person who measure outcomes were blinded
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
Tehran University of Medical Sciences, Qods St., Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-08-08, 1397/05/17
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.124
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Nasal Tip Projection
Timepoint
Nasal tip projection measurement before intervention and 3 and 12 months after intervention
Method of measurement
Goode's Ratio
2
Description
Nasal Tip Rotation
Timepoint
Nasal tip rotation measurement before intervention and 3 and 12 months after intervention
Method of measurement
Nasolabial angle
Secondary outcomes
1
Description
Patient's Satisfaction of Rhinoplasty
Timepoint
3 and 12 months after surgery
Method of measurement
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS)
2
Description
Nasal Function
Timepoint
Before, 3 and 12 months after surgery
Method of measurement
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS)
Intervention groups
1
Description
Intervention group: Using Lateral crural overlay technique by cutting lateral crura 10 mm lateral to dome and advancing medial segment over lateral segment with 2-5 mm overlap. Nasal tip projection and nasal tip rotation were measured by Goode's ratio and nasolabial angle, respectively using Photoshop software before, 3 months and 12 months after surgery. Patient's satisfaction rate and nasal function assessed by SCHNOS questionnaire before, 3 months and 12 months after rhinoplasty.
Category
Treatment - Surgery
2
Description
Intervention group: Using Medial crural overlap + lateral crural steal technique in rhinoplasty. Nasal tip projection and nasal tip rotation were measured by Goode's ratio and nasolabial angle, respectively using Photoshop software before, 3 months and 12 months after surgery. Patient's satisfaction rate and nasal function were assessed by SCHNOS questionnaire before, 3 months and 12 months after rhinoplasty.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Babak Saedi
Street address
Imam Khomeini Hospital,Keshavarz Blvd,
City
Tehran
Province
Tehran
Postal code
141979733141
Phone
+98 21 6658 1628
Email
saedi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahrain
Street address
Tehran University of Medical Sceinces, Qods St., Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
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
Babak Saedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini Hospital, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
Fax
+98 21 6658 1628
Email
saedi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Babak Saedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini Hospital, Keshavarz Blv,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
Fax
+98 21 6658 1628
Email
saedi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elaheh Darzi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Tehran university of Medical Sciences, Qods st., Keshavarz blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
Email
elaheh.darzi87@gmail.com
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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we will publish it in article
When the data will become available and for how long
we will publish it in article 2020
To whom data/document is available
nobody can have anything more than article
Under which criteria data/document could be used
we will publish it in article but nobody can have access to other data
From where data/document is obtainable
Contact with Researchers
What processes are involved for a request to access data/document