Comparison of scar outcomes of incision of alar base resection inside alar-facial groove and 2 mm above this groove in rhinoplasty patients: a randomized clinical trial
Selecting the best place to do the incision of alar base resection in rhinoplasty patients who have wide alar base
Design
Two arm, parallel group, randomized double-blinded clinical trial; phase 3 on 60 patients. Block randomization using the table of random numbers is used for random allocation.
Settings and conduct
Place: ENT ward, Imam Khomeini hospital, Tehran
Population: Rhinoplasty patients with a wide alar base
Blinding: double-blinded
Method of blinding: Individuals undergoing rhinoplasty will not be aware of the surgical technique for their alar base resection. In addition, the person who analyzes the data and the expert who assesses the scar outcome will also be blind to the surgical method performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: individuals seeking rhinoplasty who are candidates for alar base resection.
Non-inclusion criteria: history of alar scar; systemic skin diseases and collagen-vascular disorders; congenital alar deformities; repeated alar surgeries
Intervention groups
In the intervention group, the incision for alar base resection is placed in 2mm above the alar-facial groove, and in the control group, the incision for alar base resection is placed inside alar-facial groove. Other surgical techniques in all stages are similar in both groups. Skin incisions are sutured with 6-0 nylon thread.
Main outcome variables
Alar base resection scar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220420054597N1
Registration date:2022-07-18, 1401/04/27
Registration timing:registered_while_recruiting
Last update:2022-07-18, 1401/04/27
Update count:0
Registration date
2022-07-18, 1401/04/27
Registrant information
Name
Goli Golpayegani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2267 9225
Email address
golpayegani.goli@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2023-06-05, 1402/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of scar outcomes of incision of alar base resection inside alar-facial groove and 2 mm above this groove in rhinoplasty patients: a randomized clinical trial
Public title
Comparison of scar outcome in different techniques of alar base resection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
individuals seeking rhinoplasty who are candidates for alar base resection due to their wide nasal base
Exclusion criteria:
History of scar
Systemic skin diseases and collagen-vascular disorders
Congenital alar deformities
Repeated Alar surgery
Age
From 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Ten blocks, each consisting of 6 patients, will be formed. In each block, 3 patients are assigned to the intervention group and the remaining 3 patients are assigned to the control group. Randomization in each block will be obtained using the table of random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals undergoing rhinoplasty will not be aware of the surgical technique for their alar base resection. In addition, the person who analyzes the data and the expert who assesses the scar outcome will also be blind to the surgical method performed.
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,Poorsina Street, Qods Street, Enghelab Street, Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2022-03-14, 1400/12/23
Ethics committee reference number
IR.TUMS.AMIRALAM.REC.1400.064
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery
Primary outcomes
1
Description
Scar score in Visual Analogue Scale
Timepoint
Before, 1 month, 3 months, and 6 months after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Scar score in Stony Brook Scar Evaluation Scale
Timepoint
Before, 1 month, 3 months, and 6 months after the intervention
Method of measurement
Stony Brook Scar Evaluation Scale
Secondary outcomes
1
Description
Surgical complications
Timepoint
before, 1 month, 3 months, and 6 months after the intervention
Method of measurement
Surgeon's report
Intervention groups
1
Description
control group: alar base resection incision in alar-facial groove
Category
Treatment - Surgery
2
Description
Intervention group: alar base resection incision in 2mm above alar-facial groove
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Goli Golpayegani
Street address
Qarib Street
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotouhi
Street address
6th floor, Central building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
1400-3-112-55199
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
Goli Golpayegani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 601, No 10, Davalou Alley, Shariati Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1963817151
Phone
+98 21 2267 9225
Fax
Email
golpayegani.goli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Goli Golpayegani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 601, No 10, Davalou Alley, Shariati Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1963817151
Phone
+98 21 2267 9225
Fax
Email
golpayegani.goli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Goli Golpayegani
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 601, No 10, Davalou Alley, Shariati Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1963817151
Phone
+98 21 2267 9225
Fax
Email
golpayegani.goli@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
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
Not applicable
Title and more details about the data/document
Age, gender, and scar score of the patients will be shared after de-identification
When the data will become available and for how long
From 6 months after publication upon reasonable request thereafter.
To whom data/document is available
available for people working in academic institutions
Under which criteria data/document could be used
The corresponding author decides on which analyses are permitted.
From where data/document is obtainable
Golpayegani.goli@gmail.com
Goli Golpayegani
What processes are involved for a request to access data/document
the applicant's details, the proposal for which the data is requested, and the academic institution the applicant is working for.