comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal on the tear trough and scleral show in patients undergoing esthetic open rhinoplasty(a randomized clinical trial)
Comparison of the effect of high to low osteotomy by two percutaneous and internal methods on tear duct and scleral show in rhinoplasty patients.
Design
S blind RCT. The 110 envelopes with names A & B were given to patients before surgery. The patient before surgery, every one picked up one of them
A: Percutaneous ; B: Internal
Settings and conduct
Imam Khomeini Hospital Surgery Center, Ahvaz.
lateral osteotomy was performed through the skin by cutting a knife with a stab incision will be made. (Using a 2 mm osteotome and multi puncture approach)
internal osteotomy will be performed with latral osteotome ,by cutting the nasal mucosa in the pyriform opening and creating subperiosteal tunnel, maintaining Webster's triangle up to the intercanthal line,(low to high method).
When the osteotomies are completed, a greenstick fracture will be created with gentle bilateral pressure.
Participants/Inclusion and exclusion criteria
inclusion criteria: 1 -Patient satisfaction. 2-Patients over 18 y. 3- No contraindications for rhinoplasty. 4- Narrow bridge width of the nose.5- People with systemically healthy;
exclusion criteria: 1-graves ophthalmopathy (thyroid eye disease). 2- People with previous rhinoplasty. 3-People with suffering from chronic diseases. 4- People who have undergone other interventions such as neck and face lift or blepharoplasty. 5- history of fracture and trauma to the nose and face. 6- History of zygoma and naso-orbital-ethmoidal
(NOE) bone fracture. 7-People with endocrine diseases, vasculitis, or infections around the eyes. 8- People with a prominent lacrimal bone edge (sunken globe). 9- History of burns (chemical, thermal, electrical, etc.) on the face and around the eyes. 10- Clear eyelid drooping with excess skin
Intervention groups
110 patients were divided into two groups of 55 people
Main outcome variables
Change in the size of tear trough and changes in scleral show
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220903055866N1
Registration date:2022-09-20, 1401/06/29
Registration timing:registered_while_recruiting
Last update:2022-09-20, 1401/06/29
Update count:0
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
Raziyeh Moarefpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 348 2684
Email address
maryammoarefpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-24, 1401/06/02
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal on the tear trough and scleral show in patients undergoing esthetic open rhinoplasty(a randomized clinical trial)
Public title
comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal on the tear trough and scleral show in patients undergoing esthetic open rhinoplasty(a randomized clinical trial)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction
Patients over 18 years old
No contraindications for rhinoplasty surgery
narrow bridge width of the nose
People who are systemically healthy
Exclusion criteria:
1-graves ophthalmopathy (thyroid eye disease)
People who have already undergone nose surgery
People who were suffering from chronic diseases
People who have undergone other interventions such as neck ,face lift or blepharoplasty
history of fracture and trauma to the nose and face
History of zygoma bone fracture and naso-orbital-ethmoid (NOE) FX
People with endocrine diseases, vasculitis or infections around the eyes
People with a prominent lacrimal bone edge ( sunken globe )
History of burns (chemical, thermal, electrical, etc.) on the face and around the eyes.
Clear eyelid drooping with excess skin
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Single blind RCT. The 110 envelopes with names A & B were given to patients before surgery. The patient before surgery ,every one picked up one of them
A: Percutaneous ; B: Internal
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Karoon Sharghi
City
Ahvaz
Province
Khouzestan
Postal code
6136711885
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.AJUMS.REC.1401.200
Health conditions studied
1
Description of health condition studied
comparison of the effect of two low to high lateral osteotomy methods, percutaneous and internal
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Tear trough size changes
Timepoint
1 , 3 months after surgery
Method of measurement
Sonography device Iexplorer (sonic S) with linear probe. High resolution of 75 micrometers and with a frequency of 10 MHz. Tissue depth in millimeter dimensions
2
Description
Scleral show
Timepoint
1 , 3 months after surgery
Method of measurement
Photos were taken using a digital SLR camera (Canon 45OD EOS) and scleral show area was measured with Adobe CS5 Ph software. The unit is Mm2
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: internal osteotomy; internal osteotomy will be performed with a left and right lateral osteotome , by cutting the nasal mucosa in the pyriform opening and creating a subperiosteal tunnel in the osteotomy line, maintaining Webster's triangle up to the intercanthal line(L to H) method. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours
Category
Treatment - Surgery
2
Description
Intervention group: percutaneous osteotomy; approach: skin incision with stab incision. Osteotomy with 2mm osteotome and preservation of Webster Triangle. osteotomy by multi puncture and stamp-postage (L to h) bilaterally. inner dressing will be placed for 24 hours .External Splints for 7 days and recommended ice pack for 24 hours
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Imam Khomeini Hospital Surgery Center
Full name of responsible person
Ershad Hemmati
Street address
East Soroush Ave, Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136711885
Phone
+98 936 633 5930
Email
hemmati1984@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hojatollah Yousefi Manesh
Street address
West 5 Street, Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3337 1889
Email
Hojjatyoosefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Raziyeh Moarefpour
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Karoon sharghi
City
Ahvaz
Province
Khouzestan
Postal code
6136711885
Phone
+98 918 348 2684
Fax
Email
maryammoaref@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ershad Hemmati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
East Soroush Ave, Kianpars, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136711885
Phone
+98 61 3337 8489
Email
hemmati1984@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Raziyeh Moarefpour
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Karoon Sharghi
City
Ahvaz
Province
Khouzestan
Postal code
6136711885
Phone
+98 918 348 2684
Fax
Email
maryammoaref@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome:
The tear trough depth of each patient before surgery / 1 month after surgery / 3 months after surgery
Size of Scleral Show in each patient before surgery / 1 month after surgery / 3 months after surgery
When the data will become available and for how long
The data access period is from October 1401
To whom data/document is available
It will be accessible to all researchers working in academic and educational institutions
Under which criteria data/document could be used
The collected data can be used to investigate the effects of rhinoplasty treatment on periorbital components
From where data/document is obtainable
Project manager Dr. ershad Hemmati and researcher Raziyeh Moarefpour
maryammoarefpour@gmail.com
hemmati1984@gmail.com
What processes are involved for a request to access data/document
The request will be sent after receiving the applicant's email and checking the mentioned items to use the data within a period of 3 days