Effect of intermediate short osteotomy on deviated nose repair in patients who are candidate for septorhinoplasty.
Design
The eligible patients who are candidate for septorhinoplasty and will refer to Besat Hospital during the study period will be enrolled into the trial
Settings and conduct
This is a before after trial without randomization. Blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 50 years; candidate for septorhinoplast, nasal deformity of type C or S.
Exclusion criteria: Nasal trauma in the past f months; epistaxis after surgery with the need for re-sealing; trauma after surgery; nasal granulomatous disease; hypothyroiditis; nasal deformity of type tilt.
Intervention groups
Intervention group: Intermediate short osteotomy with purpose of repairing nasal deviation.
Control group: In comparison with before intervention.
Main outcome variables
Primary outcome: Assessing correction of apparent nasal deviation 6 months after operation via clinical examination.
Secondary outcome: Assessing patient's satisfaction of his/her nasal appearance and nasal breathing 6 months after operation via taking history.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N201
Registration date:2017-12-26, 1396/10/05
Registration timing:retrospective
Last update:2017-12-26, 1396/10/05
Update count:0
Registration date
2017-12-26, 1396/10/05
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
2016-06-21, 1395/04/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
Effect of intermediate short osteotomy on deviated nose repair in patients who are candidate for septorhinoplasty: a before-after clinical trial
Public title
Effect of intermediate short osteotomy on deviated nose repair in patients who are candidate for septorhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 50 years; candidate for septorhinoplast, nasal deformity of type C or S.
Exclusion criteria:
Nasal trauma in the past f months; epistaxis after surgery with the need for re-sealing; trauma after surgery; nasal granulomatous disease; hypothyroiditis; nasal deformity of type tilt.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
30
30 eligible patients who are candidate for septorhinoplasty
Actual sample size reached:
30
More than 1 sample in each individual
Actual sample size in each individual:
30
30 eligible patients who are candidate for septorhinoplasty
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This is a before after trial without randomization. Blinding is not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
1916-06-12, 1295/03/22
Ethics committee reference number
IR.UMSHA.REC.1395.152
Health conditions studied
1
Description of health condition studied
Deviated nose
ICD-10 code
S03.1XXS
ICD-10 code description
Dislocation of septal cartilage of nose, sequela
Primary outcomes
1
Description
Assessing correction of apparent nasal deviation
Timepoint
6 months after operation
Method of measurement
Via clinical examination
Secondary outcomes
1
Description
Assessing patient's satisfaction of his/her nasal appearance and nasal breathing
Timepoint
6 months after operation
Method of measurement
Via taking history
Intervention groups
1
Description
Intervention group: Intermediate short osteotomy with purpose of repairing nasal deviation.
Category
Treatment - Surgery
2
Description
Control group: In comparison with before intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Ali Dolati
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alidolati607@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Ali Dolati
Position
Resident of ENT
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
alidolati607@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Roohollah Abbasi
Position
ENT Specialist
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
r.abbasi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
All collected deidentified IPD, IPD collected for the primary outcome measure only
When the data will become available and for how long
6 months after publication
To whom data/document is available
Only available for people working in academic institutions.
Under which criteria data/document could be used
No more criteria
From where data/document is obtainable
Dr Roohollah Abbasi
ENT Specialist
9177089117
r.abbasi@umsha.ac.ir
What processes are involved for a request to access data/document