The Comparative Study on Outcome of septoplasty with and without unilateral Pyriform Turbinoplasty on concave side of septum in patients with septal deviation treated
Evaluation of both septoplasty alone and septoplasty with resect preform aperture in concave part and selecting a more suitable method for patients with nasal obstruction
Design
The study is performed in a double blind method with randomization. The studied groups are two groups of case and control.The number of samples is statistically estimated to be 60 people who are divided into 2 parallel groups of 30 people and are randomly intervened
Settings and conduct
This study is a double-blind clinical trial in patients with nasal deviation referred to Taleghani Hospital.
Septoplasty is performed for all patients, but for some patients it is performed as a random septoplasty with one-sided turbinoplasty preform on the concave side
Participants/Inclusion and exclusion criteria
Admission: Patients over 18 years of age with a diagnosis of nasal deviation who need septoplasty based on history and examination without surgery and without underlying disease: diabetes, thyroid disorders, asthma, polyposis, vasculitis and rheumatic diseases
Exit: no follow-up - characterized by associated disease
Intervention groups
Patients over 18 years of age with a diagnosis of nasal deviation who require septoplasty based on history and examination and undergo septoplasty and preform aperture resection.
In the control group, only septoplasty surgery is performed
Main outcome variables
In this study headache; Age; sex; nasal congestion; airflow; degree of nasal deviation; duration of nasal obstruction; A history of allergic rhinitis is examined
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210218050403N1
Registration date:2021-11-20, 1400/08/29
Registration timing:prospective
Last update:2021-11-20, 1400/08/29
Update count:0
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Homeira Mansurzade roodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5422 5359
Email address
mansurzade.homeira@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-10, 1400/09/19
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study on Outcome of septoplasty with and without unilateral Pyriform Turbinoplasty on concave side of septum in patients with septal deviation treated
Public title
The Comparative Study on Outcome of septoplasty with and without unilateral Pyriform Turbinoplasty on concave side of septum in patients with septal deviation treated
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pation over 18 years old
need Septoplasty : septal deviation Diagnosed according to History and Examination
Without perior Septoplasty surgery
Without comorbidity such as : Diabetes mellitus. Thyroid disorder. Asthma. Polyposis . Tomato logic and Vasculitis Didorder
Exclusion criteria:
Miss fallow up
Diagnosed Comorbidity
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization : 4 groups divided into A to C that were randomly selected from each group that septoplasty is performed randomly with concave turbinoplasty intervention or septoplasty alone. Finally in 60 samples; 30 septoplasty alone and 30 septoplasty and preform Convex turbinoplasty is performed
Blinding (investigator's opinion)
Double blinded
Blinding description
Pations know they need Septoplasty with or without priform aperture Turbinoplasty. The surgeon describe every kind of surgery.At the End pations and researcher Don't know which one done for them.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Headquarters of the Ministry of Health,No.13, Block A, Between South Flamek and Zarafshan, QodsTown,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-12-28, 1399/10/08
Ethics committee reference number
IR.SBMU.MSP.REC.1399.546
Health conditions studied
1
Description of health condition studied
Septal Deviation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nasal obstruction is the main variable of the study and 60 samples are needed to evaluate the effect of the intervention
Timepoint
Nasal obstruction is examined before the intervention and 2 months and 6 months after surgery
Method of measurement
It is examined by rhinomanometric device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergoing septplasty surgery with priform aperture resect.
Category
Treatment - Surgery
2
Description
Control group: Patients undergoing only septoplasty .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Homeira Mansourzadeh Rudi
Street address
erabi
City
Tehran
Province
Tehran
Postal code
363633636
Phone
+98 21 4486 3960
Email
mansurzade.homeira@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Unit 6, Darkeh, Arman Building, No. 42, Ahmadpour Street; Darakeh
City
Tehran
Province
Tehran
Postal code
1984100000
Phone
+98 21 2241 4024
Email
mansurzade.homeira@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homeira mansurzade rudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 6, Arman Building, No. 42, Ahmadpour Street, Darkeh
City
Tehran
Province
Tehran
Postal code
1984100000
Phone
+98 21 2241 4024
Email
mansurzade.homeira@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homeira mansurzade rudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 6,Arman Building, No. 42,Ahmadpour Street; ,Darkeh
City
Tehran
Province
Tehran
Postal code
1984100000
Phone
+98 21 2241 4024
Email
mansurzade.homeira@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homeira mansurzade rudi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Unit 6, Arman Building, No. 42, Ahmadpour Street, Darkeh
City
Tehran
Province
Tehran
Postal code
1984100000
Phone
+98 21 2241 4024
Email
mansurzade.homeira@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Manometric data and patients' questionnaires can be shared after being unidentified
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Researchers in academic institutions
Under which criteria data/document could be used
The data obtained from the questionnaire and manometry can be presented for further studies
From where data/document is obtainable
Applicants should send a request letter to the researcher's email to access the data.
mansurzade.homeira@gmail.com
What processes are involved for a request to access data/document
The applicant will apply to the mentioned e-mail by introducing himself / herself and the relevant university and the published data will be provided within two weeks