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Comparison of the effect of spreader grafts and flaps on respiration following rhinoplasty

Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171008036630N1
Registration date: 2017-12-18, 1396/09/27
Registration timing: retrospective

Last update: 2017-12-18, 1396/09/27
Update count: 0
Registration date
2017-12-18, 1396/09/27
Registrant information
Name
Ezatollah Rezaei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 110 6392
Email address
rezaeie@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences, Mashhad, Iran
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2016-09-23, 1395/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spreader grafts and flaps on respiration following rhinoplasty
Public title
The effect of spreader grafts and flaps on respiration following rhinoplasty
Purpose
Supportive
Inclusion/Exclusion criteria
Age
From 17 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
chara doctora
City
mashhad
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.MUMS.REC.1394.81

Health conditions studied

1

Description of health condition studied
rhinoplasty
ICD-10 code
J40-J47
ICD-10 code description
Chronic lower respiratory diseases

Primary outcomes

1

Description
Respiratory disorders
Timepoint
One month after surgery. Three months after surgery
Method of measurement
questionnaire

Secondary outcomes

1

Description
Nasal congestion
Timepoint
One month and three months after surgery
Method of measurement
questionnaire

Intervention groups

1

Description
The use of spreader grafts and flaps following rhinoplasty
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Ezatollah Rezaei
Street address
City
mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Street address
charah doktora
City
mashhad
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor of Plastic Surgery
Other areas of specialty/work
Street address
ahmad abad street
City
mashhad
Postal code
Phone
+98 51 3801 2841
Fax
Email
emis@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor of Plastic Surgery
Other areas of specialty/work
Street address
ahmad abad street
City
mashhad
Postal code
Phone
+95 5138012841
Fax
Email
emis@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Ezatollah Rezaei
Position
Associate professor of Plastic Surgery
Other areas of specialty/work
Street address
ahmad abad street
City
mashhad
Postal code
Phone
+98 51 3801 2841
Fax
Email
beigolis1@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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