Effect of spreader graft and autospreader flap in rhinoplasty using rhinomanometry
Design
Nasal airway flow will be measured in fifty patients with relatively similar aesthetic conditions before surgery, using rhinomanometry. Patients are randomly divided into two equal groups using a random number table, half of them will receive the spreader graft and the others will receive the autospreader flap. subjects will be fallowed three monthes post operation using same rhinomanometry
Settings and conduct
Rhinomonometry test was performed for all the patients. Cases were divided into two groups: Spreader graft group or group A And Autospreader flap group or group B and each patient would be refereed to the surgeon having one of A or B Cards in hand and the surgeon will proceed as indicated. 3 months post operation rhinomonometry test will be performed again and the results will be analyzed
Participants/Inclusion and exclusion criteria
Participants should be at the desired age range and sex and should not have a history of nose trauma and nasal surgery.
Intervention groups
Rhinoplasty using autospreader flap and spreader graft
Main outcome variables
Change in airflow after rhinoplasty in both techniques
General information
Reason for update
Acronym
none
IRCT registration information
IRCT registration number:IRCT20170711035014N2
Registration date:2018-06-06, 1397/03/16
Registration timing:retrospective
Last update:2018-06-06, 1397/03/16
Update count:0
Registration date
2018-06-06, 1397/03/16
Registrant information
Name
assila vaezi
Name of organization / entity
dental faculty
Country
Iran (Islamic Republic of)
Phone
+98 51 3893 8245
Email address
vaezia941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences Research Center
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the functional effect of spreader graft versus autospreader flap in rhinoplasty using rhinomanometry
Public title
Comparison of outcomes of two types of spreader graft versus autospreader flap in rhinoplasty using rhinomanometry
Exclusion criteria: lack of cooperation after surgery; revision surgery; no need to apply the spreader during operation.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
25 cards indicating A letter and 25 cards indicating B Letter were randomly chosen by patients: Spreader graft group or group A And Autospreader flap group or group B and each patient would be refereed to the surgeon having one of A or B Cards in hand and the surgeon will proceed as indicated
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the researcher and analyzer are unaware of the chosen card and the patient is unaware of the procedure
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Knowledge and Health City – In the end of Shahid Fakouri Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2015-12-14, 1394/09/23
Ethics committee reference number
IR.MUMS.SD.REC.1394.239
Health conditions studied
1
Description of health condition studied
Nasal functional problems
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nasal flow change during inhale/exhale in both cavities
Timepoint
Before operation and thirty days post operation
Method of measurement
Rhinomanometry
Secondary outcomes
1
Description
Aesthetic outcomes and changes of graft application in Tip elevation and tip rotation in both procedures
Timepoint
Not included in the study
Method of measurement
Not included in the study
Intervention groups
1
Description
Group1: Patients having surgery using autospreader flap.
Category
Treatment - Surgery
2
Description
Group 2: patients having surgery using spreader graft.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospital
Full name of responsible person
Mahdi Gholami
Street address
Ahmad abad Ave., Mashhad Town,
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0000
Email
Quaem.Medical.Center@mums.ac
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 3007
Email
assilavz@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad Dental faculty
Full name of responsible person
Assila Vaezi
Position
OMFS Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
no. 99, 13th Daneshjoo St.
City
Mashhad
Province
South Khorasan
Postal code
9188976391
Phone
+98 51 3893 8245
Fax
Email
assilavz@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdi Gholami
Position
OMF Surgeon
Latest degree
Specialist
Other areas of specialty/work
Street address
Surgical department of Mashhad Dental Faculty
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3893 8245
Fax
Email
gholami42143@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Faculty
Full name of responsible person
Assila Vaezi
Position
OMFS Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 99, 13th Daneshjoo St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188976391
Phone
+98 51 3893 8245
Fax
Email
assilavz@gmail.com
Web page address
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
Due to the large number of participants and the study of rhinomanometry in the form of charts and tables requiring expert examination, there is no need to publish the results.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Airflow and air resistant totally and in right and left nostril
When the data will become available and for how long
One year
To whom data/document is available
Academic responsible
Under which criteria data/document could be used
In cases of statistics analysis and standardization of study circumstances
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document
Rhinomanometry before and 3 month after rhinoplasty