If the complication of using piezoelectric surgery is reduced, it can replace the usual osteotomy.
Design
Randomised, clinical trial double blinded for patients and postoperative care and outcome assessment with parallel group on 26 patients.
Settings and conduct
26 patients in the maxillofacial surgery service of Imam Khomeini Hospital in Ahvaz at the end of rhinoplasty
They are randomly inserted into the piezo ostomy group (study group) or the 2 mm osteotomy group (control group). Each side that is ostomy with one method is ostomy with the other with another device. Lateral osteotomy will be performed externally through the skin using the instrument of choice without lifting the periosteum. And below the medial canthus will be given the skin and superficial muscle aponeurotic tissue (SMAS) and periosteum.
Using a small Pizzo PZ3 pen head (Piezotome Acteon Group, Mérignac, France), it will be inserted through the incisions to reach the nasal bone.
Participants/Inclusion and exclusion criteria
Patient intrusion criteria:
People over 18 years old
Patients with broad dorsum
Patient extrusion criteria:
History of rhinoplasty
nose deviation
History of respiratory problems
Patients with narrow duodenum
Intervention groups
All patients who meet these criteria are randomly assigned to the piezo osteotomy group (study group) or the 2 mm osteotomy group (control group). Then the priority of right or left osteotomy is randomly selected, but in the end the two groups must be the same in terms of the number of initial piezo or osteotomy and right and left. It should be noted that each side that was osteotomy with one method, the other side is osteotomy with another device.
Main outcome variables
Investigating the amount of bleeding, mucosal rupture, ecchymosis, swelling, pain, skin scar and integrity of the nasal bone and the amount of bone spore in using of piezoelectric rhinoplasty
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220104053618N1
Registration date:2022-09-23, 1401/07/01
Registration timing:registered_while_recruiting
Last update:2022-09-23, 1401/07/01
Update count:0
Registration date
2022-09-23, 1401/07/01
Registrant information
Name
Bahare Yaghoubi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3223 4448
Email address
yaghoubi.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-17, 1401/06/26
Expected recruitment end date
2022-10-17, 1401/07/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
External perforating osteotomy in rhinoplasty comparing ultrasonic cut vs traditional osteotome: A preliminary randomized crossover clinical trial
Public title
External perforating osteotomy in rhinoplasty with ultrasonic cut
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
age over18 years old
patients without any diseases
Exclusion criteria:
history of rhinoplasty
deviation
respiratory problems
narrow dorsum
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple and individual way
Before conducting the study on 26 patients, an envelope will be given to the patients, which will be related to the side of osteotomy with piezoelectric (right or left) and in order to be equal, interventions will be performed randomly in 13 cases on the right side and in the other 13 samples. It will be done on the left
And the envelope will be randomly given to the patient, and the surgeon will take the envelope from the patient in the operating room and based on that, he will perform the selected side with piezoelectric and the opposite side with a 2 mm osteotome. The piezo osteotomy side will compare the two sides.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are selected and entered into the study without knowing which side was used for which of the two osteotomy methods, and all patients who meet the mentioned criteria are randomly admitted to the piezo osteotomy group (study group) or 2 mm osteotomy (control group).
The person in charge of evaluating patients, clinical results and complications of surgery at the end of surgery and in subsequent follow-up is unaware of the grouping process and the type of osteotomy device on both sides.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of medical sciences
Street address
Golestan st. ,Ahvaz , Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.AJUMS.REC.1401.252
Health conditions studied
1
Description of health condition studied
nose deformity
ICD-10 code
Q30.9
ICD-10 code description
Congenital malformation of nose, unspecified
Primary outcomes
1
Description
Eyelid ecchymosis
Timepoint
Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation
Method of measurement
Kara and Gökalan classification system for ecchymosis: grade 1: ecchymosis of the medial third of the upper or lower eyelid or both - grade 2: bruising of the medial two thirds of the upper or lower eyelid or both - grade 3: bruising of the entire length of the upper or lower eyelid or both
2
Description
eyelid edema
Timepoint
Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation
Method of measurement
Kara and Gökalang's classification system for swelling: Grade 1: no pupil covering interference by Hagrid's eyelids - 2: little pupil covering by eyelid swelling - Grade 3: complete pupil covering by significant swelling of Hagrid's eyelids 4: complete closure of the eyes
3
Description
Subconjunctival hemorrhage
Timepoint
Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation.
Method of measurement
Classification system for open and Gökalan Subconjunctival hemorrhage: grade 1: presence of Subconjunctival hemorrhage up to 50% of the congeal surface - grade 2: presence of Subconjunctival hemorrhage with 90% of the congeal surface
4
Description
pain
Timepoint
Comparison and examination of ecchymosis on two sides will be done on days 2, 3, 7, 30 after the operation.
Method of measurement
Pain will be evaluated using a visual analog scale (VAS), in this way, the patient will be given a line marked from 0 to 10, and during three days, he will mark his pain level on the right and left side separately. It means that the number 0 indicates no pain and 10 is the highest value.
5
Description
bleeding
Timepoint
During the operation and immediately post operation
Method of measurement
visual
6
Description
scar
Timepoint
Skin scars will be evaluated one month after surgery.
Method of measurement
The two sides will be compared visually
7
Description
Force for the mobilization of nasal bones
Timepoint
During operation
Method of measurement
Comparison of the amount of pressure required to mobilization of the nasal bones on two sides
8
Description
Uniformity of the osteotomized wall
Timepoint
During operation
Method of measurement
Absence of spores on touch
9
Description
mucosal injury
Timepoint
immediate post operation
Method of measurement
examined endoscopically
10
Description
Bruising and edema
Timepoint
Immediate Post operation
Method of measurement
Visually
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Lateral osteotomy using Action piezoelectric device made in France on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on one side with piezoelectric using a small angle pen head Dar PZ3 with washing 100 ml per minute and mode D2 externally through 2 2 mm skin incisions; The first incision will be made in the caudal area and the second incision will be made 8-10 mm more medial than the medial canthus without lifting the periosteum.
Category
Treatment - Surgery
2
Description
In the control side, the 2-mm wide sharp osteotomes was used on a sample of 26 person under general anesthesia after 7-10 minutes of injection of lidocaine containing adrenaline 1:100,000 randomly on the side opposite to the intervention side (for example, if osteotomy with piezo On the right side, the osteotomy will be performed with the traditional method on the left side and this procedure will be performed randomly on both sides) with a traditional perforating technique.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Department of Maxillofacial Surgery, Imam Khomeini Hospital, Ahvaz
Street address
Azadegan st, east saheli Blvd., ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3292 3985
Email
Bahareh_yaghoobi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoush Zakerkish
Street address
Golestan st , west saheli Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 0000
Email
Aduaum@ajums.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
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
بهاره یعقوبی
Position
Resident of oral and maxillofacial surgery
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 48 , West Sepid Ave., Kian Abad St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155738767
Phone
+98 21 3223 4448
Email
Bahareh_yaghoobi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Khiabani Savojbolaghchi
Position
Consultant, Professor, Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Jondishapour Medical Science University, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3320 5169
Email
khiabani_ak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Ghasabzadeh Naieni
Position
Consultant, Professor, Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Jondishapour Medical Science University, Golestan Highway, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3320 5169
Email
ghasabzadeh-m@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
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
This study will be approved by the university ethics committee and will receive an IRCT code.
All patients after obtaining informed consent and explanation of the surgical approach and complications randomly entered into piezo stoma group (study group) or 2 mm osteotomy group (control group). all data and postoperative complications in two groups are compared and all of them will be examined on days 2, 3, 7, and 30 for pain, swelling, ecchymosis , subconjunctival hemorrhage, and skin scars on both sides of the face, as well as the integrity of the osteotomized lateral wall, the presence of residual deformity, and bone spur immediately post operation will be examined by palpation and mucosal tears and damage will be evaluated with an endoscope.
All data can be published after analysis.
When the data will become available and for how long
The data access period is about 3 months after the patients' follow-up from December 1401.
To whom data/document is available
The data will be accessible to all researchers working in academic and educational institutions.
Under which criteria data/document could be used
These data can be used to compare rhinoplasty surgery with piezoelectric and the usual method and to use this approach. The analyzes performed on the data will be reported, which can be used for further studies.
From where data/document is obtainable
To receive the data, the researchers can contact with Dr. Kazem Saujblagachi Khiabani (Khiabani_ak@yahoo.com) and the researcher, Dr. Bahare Yaghoobi (Bahar69.yaghoobi@gmail.com).
What processes are involved for a request to access data/document
After receiving the applicant's email, the data will be available to researchers within three days.