Comparing the effect of "Lateral Crural Overlay" with "Lateral Crural Strut Graft withTransposition technique" on Cephalic Malposition in septorhinoplasty
Comparing the effect of "Lateral Crural Overlay" with "Lateral Crural Strut Graft withTransposition technique" on Cephalic Malposition in septorhinoplasty
Design
Two arm parallel group، double-blinded, randomized clinical trial
Settings and conduct
The current study will be conducted in Alzahra Hospital affiliated to Isfahan University of Medical Sciences. The patients with cephalic malposition who are candidate for septorhinoplasty surgery will be block-randomized to the surgical treatment of either lateral crural overlay or Lateral Crural Strut Graft withTransposition technique, and the surgical outcomes will be compared. The patients and the statistician will be blinded to the type of surgery.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1) 18-year-old patients and older,
2) Lateral Crural Cephalic Malposition in primary septorhinoplasty candidates
Unmet Criteria:
1) Prior history of septoplasty or rhinoplasty
2) Sinonasal Pathology:Chronic Sinusitis, Nasal Polyposis, Asthma, Allergic Rhinitis
Intervention groups
"Lateral Crural Overlay" Group:
The lateral crura is incised with the proportion of one-third lateral and two-third medial. Vestibular skin is elevated and the cut cartilage is placed caudally from the anterior part in normal anatomical position, and then will be sutured.
"Lateral Crural Strut Graft with transposition
technique" group:
The most lateral part of the lateral crura is divided into two parts vertically. Then, the vestibular skin is elevated from the lateral to the medial part of the lateral crura. A subcutaneous pocket is placed in a caudal position between accessory cartilage and alar groove. Eventually, the freed lateral crura will be inserted into new created cephalic packets, and the skin will become intact.
Main outcome variables
Lateral Crural Angle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190801044401N1
Registration date:2019-12-29, 1398/10/08
Registration timing:retrospective
Last update:2019-12-29, 1398/10/08
Update count:0
Registration date
2019-12-29, 1398/10/08
Registrant information
Name
Hossein Ghazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
h.ghazavi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2020-06-05, 1399/03/16
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2019-09-06, 1398/06/15
Trial completion date
2019-09-11, 1398/06/20
Scientific title
Comparing the effect of "Lateral Crural Overlay" with "Lateral Crural Strut Graft withTransposition technique" on Cephalic Malposition in septorhinoplasty
Public title
Comparing the effect of two different techniques on Cephalic Malposition in septorhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
"Lateral Crural Cephalic Malposition" in primary septorhinoplasty candidates
18-year-old patients and older
Exclusion criteria:
Prior history of septoplasty
Sinonasal Pathology: Chronic Sinusitis,Nasal Plyposis, Asthma, Allergic Rhinitis
Prior history of rhinoplasty
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization took place in the operation room by opening a numbered envelope. The envelopes were prepared by the trial statistician by using the block randomization method (block size of 4). Investigators and individuals who analyzed the outcomes were unaware of the randomization schedule.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients were unaware of the method of surgery as the randomization was performed in operation room. Besides, the statistician recieved the encoded information, therefore, he was unaware of each of the codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.MUI.REC.1396.3.458
Health conditions studied
1
Description of health condition studied
Lateral Crural Cephalic Malposition in primary Septorhinoplasty Candidates
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Lateral Crural Angle:the angle between longitudinal lateral cruel axis and midline
Timepoint
Preoperation and one year postoperation
Method of measurement
Protractor
Secondary outcomes
empty
Intervention groups
1
Description
Control group:Cephalic Malposition will be corrected by "Lateral Crural Overlay" technique
Category
Treatment - Surgery
2
Description
Intervention group:Cephalic Malposition will be corrected by "Lateral Crural Strut Graft withTransposition technique"with transposition technique.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Hossein Ghazavi
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
h.ghazavi@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mojgan Mortazavi
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
Email
mortazavi@med.mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ghazavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Soffe Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 3 1668 5555
Email
h.ghazavi@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ghazavi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
0098 3 1668 5555
Email
h.ghazavi@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Ghazavi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
h.ghazavi@mui.ac.ir
Web page address
http://alzahra.mui.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
The data include the patients' demographic information and data related to cephalic malposition that may be accessible only by the permission of the responsible professor
When the data will become available and for how long
In the case of the professor permission, the data are accessible at any time
To whom data/document is available
Only the people can access the data that are confirmed by the professor responsible for the study
Under which criteria data/document could be used
In order to publish similar studies and by the permission of the professor responsible or the study, the data will be provided
From where data/document is obtainable
It should be contacted to the professor responsible for the study
What processes are involved for a request to access data/document
It should be contacted to the professor through call or email