Comparing clinical findings of rhinoplasty using a novel combination method of osteotome and reciprocal saw with conventional method of osteotome
Design
The plan will attempt to compare clinical findings of rhinoplasty using osteotomy and saw 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 at second and seventh day after surgery.
Settings and conduct
This prospective study will conducted in patients referred to Apadana Hospital of Ahvaz and Dey Limited Surgery Center of Arak for rhinoplasty in the age range of 14 to 50 years old regardless of gender.
Participants/Inclusion and exclusion criteria
Exclusion criteria are patients with any kind of renal deformity, no anesthesia contraindication (American Society of Anesthesiologists physical status I and II), no serious airway malformation (septal deviation, breathing dysfunction).
Inclusion criterion is men and women between the ages of 14 and 50 require surgery for rhinoplasty.
Intervention groups
The study was divided into two groups of intervention including osteotome and raw and control including traditional osteotomy.
Main outcome variables
Pain, ecchymosis, swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170316033094N2
Registration date:2020-07-29, 1399/05/08
Registration timing:registered_while_recruiting
Last update:2020-07-29, 1399/05/08
Update count:0
Registration date
2020-07-29, 1399/05/08
Registrant information
Name
Mehdi Heidarizade
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3221 6104
Email address
heidarizadeh.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing clinical findings of rhinoplasty using a novel combination method of osteotome and reciprocal saw with conventional method of osteotomy
Public title
Novel approach in rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with any kind of nasal deformity
No anesthesia contraindication (American Society of Anesthesiologists physical status I and II)
No serious airway malformation (septal deviation, breathing dysfunction).
Men and women between the ages of 14 and 50 require surgery for rhinoplasty
Exclusion criteria:
Pregnant women
Taking antidepressant medications
Refusal to participate
Age
From 14 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
Patients are randomly divided into two groups using the block randomization method with the following sequences: AABB, ABAB, ABBA, BAAB, and BABA. Group A undergoes the conventional method of osteotomy, and group B undergoes combination novel method of osteotomy and saw.
Concealment will carried out using pocket concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient will blind about the group of intervention. Due to the finding assessment will performed after surgery and the method applied is not detectable after surgery hence outcome assessor is automatically blinded regarding the group f intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Arak University of Medical Sciences
Street address
Research and Technology Deputy of Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.ARAKMU.REC.1399.085
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: This method performed using two instruments together for rhinoplasty including chisel osteotome and reciprocal saw. During the surgery the time of breaking the nasal bones using these two instrument is recorded based on second. In addition, the outcome variables including echymosis, pain, edema and patient's satisfaction are measured at two and seven days after day surgery.
Category
Treatment - Surgery
2
Description
Control group:Osteotome
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dey Limited Surgery Center
Full name of responsible person
Mehdi Heidarizade
Street address
In front of the Department of Transfusion Medicine, Pharmacy upper floor Bu Ali, Street Shahid Shiroodi (Khoram), Arak, Iran.
City
Arak
Province
Markazi
Postal code
3919693345
Phone
+98 86 3312 7175
Fax
+98 86 3313 3147
Email
info@dsca.ir
Web page address
http://www.deylimitedsurgerycenter.ir/
2
Recruitment center
Name of recruitment center
Apadana Hospital
Full name of responsible person
Omid Ghasemzadeh
Street address
North Soroosh Street, Ghods Highway, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3377 0093
Fax
+98 61 3377 2029
Email
info@ajums.ac.ir
Web page address
http://www.ahvaz-apadana.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizade
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
1
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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizade
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizadeh
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
ِDentistry Faculty, Arak University of Medical SciencesA'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizade
Position
Assistant Professor of OMFS
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Dentistry Faculty, Arak University of Medical SciencesA'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
drmehdiheidarizadehomfs@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD