Comparison of piezosurgery and conventional external osteotomy post rhinoplasty morbidities (ecchymosis, edema, pain) at imam khomeini hospital, 2021_2023
Design
Tow parallel group, double blinded, randomized with fourth block, sample size 60.
Settings and conduct
In this study 60 rhinoplasty clients chosen from patients of ENT clinic at Imam Khomeini hospital in 1400_1401 and after an informed consent we randomized them in 2 group with tow different way of external osteotomy ( piezoelectric or conventional osteotomy) and after surgery we compared their post operation morbidities (edema, ecchymosis, pain) by 2 ENT residents who are blinded about the target of the study, by using their post operation photography in day 4,7 after surgery.
Participants/Inclusion and exclusion criteria
Inclusive criteria:
Patient consent
Patient without any contraindication for rhinoplasty
Exclusive criteria:
Revision surgery
Severe deformities
Anticoagulant medication users
Past medical history
Current smokers
Intervention groups
In this study in a group we do external osteotomy with piezoelectric osteotom and in the other group we do it with conventional 2 millimeter osteotom.
Main outcome variables
post rhinoplasty edema, ecchymosis and pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110514006468N2
Registration date:2021-11-21, 1400/08/30
Registration timing:prospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Amin Amali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
a_amali@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of piezosurgery and conventional external osteotomy post rhinoplasty morbidities (ecchymosis, edema, pain)
Public title
Comparison of piezosurgery and conventional external osteotomy post rhinoplasty morbidities (ecchymosis, edema, pain) at imam khomeini hospital, 2021_2023
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patient consent
patient without any contraindication for rhinoplasty
Exclusion criteria:
revision surgery
severe deformities
anticoagulant medication users
past medical history
current smokers
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
we use block randomization. we have blocks of four intervention (A) and four of control (B) groups and write them from 1-6 on cards and put them in a pocket, then choose them by chance and make a sequence of cards. We import patients of interventional or control group of our study from these sequences.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients, (despite informed consent) will not realize their group.
In this study post operation assessors will not know the patients group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Tehran university of medical sience
Street address
Vice chancellery for research and technology of Tehran university of medical sience, , Qods Ave, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1981613875
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.152
Health conditions studied
1
Description of health condition studied
Rhinoplasty post operation morbidities (edema, ecchymosis, pain)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
post rhinoplasty edema
Timepoint
4 and 7 day after surgery
Method of measurement
Kara and Gökalan (Adopted by Yucel)
2
Description
Post rhinoplasty ecchymosis
Timepoint
4 and 7 day after surgery
Method of measurement
Kara and Gökalan (Adopted by Yucel)
3
Description
pain
Timepoint
4 and 7 day after surgery
Method of measurement
10 point pain ruler scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group we will do external osteotomy with piezoelectric device ( POEZOTOME M+ ( The ultrasonic expert )) of COMEO company with engine speed 36-28 Khz with 90 angled straight blade (RHS5) and after external incisor (max use of each blade: 3 patient). Other parts of surgery is completely same with control group.
Category
Treatment - Surgery
2
Description
Control group: In this group we will do external osteotomy with conventional 2 millimeter straight blade.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Otorhynolaryngology clinic of Imam Khomeini hospital complex
Full name of responsible person
Amin Amali
Street address
Imam Khomeini hospital complex , Bagherkhan Ave, South Chamran highway
City
Tehran
Province
Tehran
Postal code
1981613875
Phone
+98 21 2211 4286
Email
Zohreh.ghasemii92@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeyan
Street address
Qods Ave, Keshavarz Blv,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7381 8898
Email
vcr@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
Amin Amali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Khomeini hospital complex , Bagherkhan Ave, South Chamran highway
City
Tehran
Province
Tehran
Postal code
141765371
Phone
982161190
Email
zohreh.ghasemii92@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Amali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
South Chamran highway, Bagherkhan Blv, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
141765371
Phone
00982161190
Email
ZOHREH.GHASEMII92@GMAIL.COM
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amin Amali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
South Chamran highway, Bagherkhan Ave, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
141765371
Phone
982161190
Email
ZOHREH.GHASEMII92@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
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