Objectives: to compare the functional and aesthetic outcomes of spreader graft vs autospreader graft in rhinoplasty surgeries
Design: a cotrolled parallel randomized trial
Setting and conduct: Panzdah khordad hospital, a referal hospital in Tehran
Participants : Patinent aged 18-60 who referred to Panzdah-e-Khordad hospital for elective rhinoplasty during years 2013-2014 there is no exclusion criteria
Intervention: spreader graft vs autospreader graft
main outcome measures : Nasal flow and resistance using rhinomanometery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100719444N1
Registration date:2014-12-26, 1393/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-26, 1393/10/05
Registrant information
Name
Ataollah Heidari
Name of organization / entity
15th Khordad hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6687 5090
Email address
ata_heidari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shaheed Beheshti University of medical Sciences
Expected recruitment start date
2013-01-01, 1391/10/12
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of manometery changes in rhinoplasty autospreader vs spreader graft techniques in patients referred for cosmetic rhinoplasty
Public title
comparison of manometery changes in rhinoplasty autospreader vs spreader graft techniques in patients referred for cosmetic rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Patients reffered for rhinoplasty, age 18-60 years.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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
Shahib Beheshti University of Medical Sciences ethical committee
Street address
Shahib Beheshti University of Medical Sciences ethical committee, Resarch deputy, Velenjak
City
Tehran
Postal code
Approval date
2013-09-08, 1392/06/17
Ethics committee reference number
0308/8462
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
J34
ICD-10 code description
Other disorders of nose and nasal sinuses
Primary outcomes
1
Description
Nasal flow
Timepoint
1 month after intervention
Method of measurement
Rhinomanometer
Secondary outcomes
1
Description
Total nasal airway resistance
Timepoint
1 month after intervention
Method of measurement
Manometery
Intervention groups
1
Description
Auto spreader flap technic in rhinoplasty
Category
Treatment - Surgery
2
Description
Spreader flap technic in rhinoplasty
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
15th Khordad Hospital
Full name of responsible person
Ataolah Heydari
Street address
15th Khordad Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ali Peyvandi
Street address
15th Khordad hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, of Shahid Beheshti 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
Shahid Beheshti university of medical sciences
Full name of responsible person
Ataollah Heidari
Position
Surgeon
Other areas of specialty/work
Street address
15th Khordad Hospitoal, South Aban st., Karimkhan st.
City
Tehran
Postal code
Phone
+98 21 6687 5090
Fax
Email
ata_heidari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Ataollah Heidari
Position
Plastic surgeon, fellowship
Other areas of specialty/work
Street address
15 Khordad Hospital, South Abab st. Karimkhan st,
City
Tehran
Postal code
Phone
+98 21 6687 5090
Fax
Email
ata_heidari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Ataollah Heidari
Position
surgeon
Other areas of specialty/work
Street address
15th Khordad Hospital, south Aban st, Karimkhan
City
Tehran
Postal code
Phone
+98 21 6687 5090
Fax
Email
ata_heidari@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)