Comparative study of two methods of internal osteotomy in lateral nasal bones in rhinoplasty by osteotomy and pizosurgery
Design
The plan will attempt to compare internal osteotomy using osteotomy and piezoelectric surgery in two intervention groups.
Patients are randomly divided into two groups. The consequences of pain and ecchymosis and swelling caused by nose bone osteotomy are examined.
Settings and conduct
This prospective study was conducted in patients referred to Ahvaz Imam Khomeini Hospital for rhinoplasty in the age range of 18 to 40 years old regardless of gender.
Participants/Inclusion and exclusion criteria
Population under study: Men and women between the ages of 18 and 40 require surgery for rhinoplasty.
Entry Criteria: Rhinoplasty is a cosmetic effect. The age of the patients is between 18 and 40 years.
Non-compliance criteria: clear deviation of hump nasal septum. Very high respiratory problems caused by past nose problems.
Intervention groups
Two intervention groups for internal osteotomy in lateral nasal bone in rhinoplasty by osteotomy and another, Pizzorrhary
Main outcome variables
Pain, ecchymosis, swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170218032643N2
Registration date:2018-03-27, 1397/01/07
Registration timing:retrospective
Last update:2018-03-27, 1397/01/07
Update count:0
Registration date
2018-03-27, 1397/01/07
Registrant information
Name
Amir Khosro Mohiti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 1717
Email address
mohiti.akh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-09-05, 1396/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post operative complications of two internal osteotomy methods in rhinoplasty: piezosurgery vs osteotomy
Public title
Post operative complications of two internal osteotomy method in rhinoplasty: piezosurgery vs osteotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is between 18 and 40 years
Requires rhinoplasty
Exclusion criteria:
Clear deviation in the nasal septum
Respiratory problems due to nasal problems
The history nose surgery
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly divided into two groups regardless of gender. All surgeries are performed by a surgeon. The study will be reviewed by a surgeon and a specialized assistant.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2016-01-12, 1394/10/22
Ethics committee reference number
IR.AJUMS.REC.1395.531
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
J34
ICD-10 code description
Other and unspecified disorders of nose and nasal sinuses
Primary outcomes
1
Description
Edema
Timepoint
The second and seventh day after surgery
Method of measurement
Grade 1: The upper and lower eyelids do not interfere with the pupil.Grade 2: A brief coverage of the pupils with some inflation in the eyelids.Grade 3: Complete coverage of the pupil with significant swelling in the eyelids.Grade 4: Complete Eye Closure
2
Description
Pain
Timepoint
First, second and third after surgery
Method of measurement
VAS scale
3
Description
Ecchymosis
Timepoint
Day two and seven after surgery
Method of measurement
The KARA method is used to assess ecchymosis. In this way, the results are categorized as follows: Grade 1: Kimos to 3/1 lower or upper eyelid, or both. Grade 2: Echimoses up to 2/2 lower or upper eyelid or both. Grade 3: Eclipse of the entire lower or upper eyelid, or both
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Surgery
2
Description
Intervention group:
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Amir Khosro Mohiti
Street address
Azadegan Blvd, Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
mohiti.akh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Ahvaz Jundishapur University of Medical
Full name of responsible person
Mohammad Badavi
Street address
Ahvaz, Golestan Blvd, Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3373 8594
Email
info@ajums.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 and Technology of Ahvaz Jundishapur University of Medical
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
Amir Khosro Mohiti
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Azadegan Blvd, Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 51 3604 1717
Fax
+98 51 3604 1717
Email
mohiti.akh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamid Reza Fallahi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Azadegan Blvd, Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 61 3221 6104
Email
fallahi.h@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir Khosro Mohiti
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Azadegan Blvd, Imam khomeini hospital
City
Ahvaz
Province
Khouzestan
Postal code
1234587659
Phone
+98 51 3604 1717
Fax
+98 51 3604 1717
Email
mohiti.akh@ajums.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available