Comparison between doing and not doing spreader(graft or flap) in rhinoplasty patients with hump more than 3mm with respect to aesthetic and respiratory issues
Comparison between doing and not doing spreader (graft or flap) in rhinoplasty patients with a hump of more than 3 mm in terms of beauty and respiration
Design
A clinical trial with the control group, double-blind, randomized, on 60 patients
Settings and conduct
The present study is about comparison between doing and not doing spreader (graft or flap) in rhinoplasty patients with a hump of more than 3 mm in terms of beauty and respiration. This study is performed in the plastic surgery department of Taleghani Hospital in Ahvaz. The study is a double-blind clinical trial. Patients and the evaluator of the study outcome are blinded to the grouping of patients.
Participants/Inclusion and exclusion criteria
Rhinoplasty patients who do not have clinical problems to enter the study. Full patient consent is required to enter the study.
Intervention groups
In the first intervention group, rhinoplasty is performed by spreader graft method and in the second intervention group, surgery is performed by spreader flap method.
Main outcome variables
Mean score of rhinomanometric test indices; frequency distribution of patients 'satisfaction in terms of aesthetics; frequency distribution of patients' satisfaction in terms of respiratory function; frequency distribution of nasal congestion and its severity (mild, moderate, severe) based on examination; frequency distribution of presence or absence Cottle sign
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201109049320N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
roozbeh rahbar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8571
Email address
rahbar-r@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between doing and not doing spreader(graft or flap) in rhinoplasty patients with hump more than 3mm with respect to aesthetic and respiratory issues
Public title
The effect of spreader on the aesthetic and respiratory issues of rhinoplasty patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of clinical problems for the patient
Patient consent to participate in the study
Exclusion criteria:
Existence of structural problems such as: nasal obstruction and a history of deformity that requires rhinoplasty.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, eligible patients are divided into group undergoing rhinoplasty by spreader graft method and the group undergoing surgery by spreader flap method and the group of control patients. Samples are included in this study by the simple randomization method. To group patients in a simple random way, the letters A, B and C are written on 60 pieces of paper with equal dimensions (each letter is written on 20 pieces of paper). After entering, each patient selects one of the papers with an equal chance and thus the patient group is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is not informed that he or she is in the control or sample group. The specialist who performs rhinomanometric tests on patients before and after surgery is unaware of those in the control or sample group. The evaluator who evaluates the results of the study is unaware of the people in the control or sample group. The person analyzing the study data is unaware of the people in the control or sample group.
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
Ethics Committee, Vice Chancellor for Research, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Approval date
2020-10-13, 1399/07/22
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.071
Health conditions studied
1
Description of health condition studied
Rhinoplasty patients with a hump greater than 3 mm
ICD-10 code
J34.8
ICD-10 code description
Other specified disorders of nose and nasal sinuses
Primary outcomes
1
Description
Nasal congestion
Timepoint
Before and after surgery
Method of measurement
Breathing quality score
Secondary outcomes
1
Description
Severe deviation of the nasal septum
Timepoint
Before and after surgery
Method of measurement
clinical examination
2
Description
The presence or absence of shortness of breath
Timepoint
Before and after surgery
Method of measurement
Clinical examination
3
Description
Right nasal resistance
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
4
Description
Left nasal resistance
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
5
Description
Total resistance
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
6
Description
Right nasal airflow
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
7
Description
Left nasal airflow
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
8
Description
Total air flow (units: Pascals per milliliter per second)
Timepoint
Before and after surgery
Method of measurement
Rhinoomanometry test by active anterior rhinomanometry according to the protocol of the International Committee for Standardization
Intervention groups
1
Description
Intervention group: Spreader (graft or flap) in rhinoplasty patients with a hump of more than 3 mm
Category
Treatment - Surgery
2
Description
Control group: Do not do a spreader (graft or flap) in rhinoplasty patients with a hammer larger than 3 mm
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Taleghani Hospital
Full name of responsible person
Roozbeh Rahbar
Street address
Plastic surgery department, Taleghani hospital, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Phone
+98 61 3554 0254
Email
rahbar-r@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Vice Chancellor for Research, Ahvaz Jundishapur university of medical sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Phone
+98 61 3554 0254
Email
rahbar-r@ajums.ac.ir
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
Roozbeh Rahbar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Plastic surgery department, Taleghani hospital, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Phone
061355402546
Email
rahbar-r@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roozbeh Rahbar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Plastic surgery department, Taleghani hospital, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Phone
061355402546
Email
rahbar-r@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Roozbeh Rahbar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic Surgery
Street address
Plastic surgery department, Taleghani hospital, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
61877954386
Phone
061355402546
Email
rahbar-r@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