Determining the Effect of Alar Contour Graft in Improvement of Respiratory Problems and Patients’ Satisfaction after Rhinoplasty Based on Vertical Dome Division
Aim of the study: Determination the effect of alar contour graft in improvement of respiratory problems after rhinoplasty in patients undergoing septorhinoplasty based on vertical dome division technique.
Key Inclusion Criteria: Candidate patients for rhinoplasty
Key Exclusion Criteria: Patients with nasal polyp; systemic disorders that postpones the wound healing, history of nasal trauma; psychiatric disorders preventing an unbiased post-op evaluation; severe septal deviation; congenital deformity and using spreader graft with any causes.
Study Population: Two hundred and eleven candidate patients for rhinoplastic surgery. Random division: 111patients in interventional group, 100 patients in control group.
Study Intervention: in interventional group: rhinoplasty based on vertical dome division technique using alar contour graft, in control group: rhinoplasty based on vertical dome division technique.
Primary outcome: Evaluation of respiratory problem before, 1 and 6 months after the surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062322889N1
Registration date:2015-07-19, 1394/04/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Saeid Pourseirafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 681 2273
Email address
pourseirafi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the Effect of Alar Contour Graft in Improvement of Respiratory Problems and Patients’ Satisfaction after Rhinoplasty Based on Vertical Dome Division
Public title
Effect of using Alar Contour Graft in Improvement of Respiratory Problems and Patients’ Satisfaction after Rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The patients candidate for rhinoplasty in 1393 in Khalili Hospital, Shiraz; Completing consent form; Completing demographic information and questionnaire
Exclusion criteria: Patient’s with nasal polyp; Systemic disorders that postpones the wound healing; History of nasal trauma; Psychiatric disorders preventing an unbiased post-op evaluation; Poor follow up; Severe septal deviation diagnosed by P/E preoperatively; Congenital deformity; Using spreader graft with any causes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
211
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Medical college, Imam Hossein square, Zand street,Shiraz
City
Shiraz
Postal code
7134845794
Approval date
2014-05-31, 1393/03/10
Ethics committee reference number
CT-P-9359-5679
Health conditions studied
1
Description of health condition studied
patients scheduled for rhinoplastiy surgery
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
respiratory problem including airway obstruction
Timepoint
before the surgery, 1 month and 6 months after the surgery
Method of measurement
questionnaire and physical exam
Secondary outcomes
1
Description
Patients' satisfaction from surgary
Timepoint
1 month and 6 months after the surgery
Method of measurement
questionnaire and physical exam
Intervention groups
1
Description
control group:rhinoplasty based onvertical dome division technique
Category
Treatment - Surgery
2
Description
intervention group:rhinoplasty based onvertical dome division technique using alar contour graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Dr.Saeid Pourseirafi
Street address
Khalili hospital, Khalili street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Reza Kaboodkhani
Street address
Medical College, Imam Hossein square, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.com pourseirafi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.compourseirafi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
ENT Department, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Saeid Pourseirafi
Position
ENT resident
Other areas of specialty/work
Street address
ENT Department, Shiraz University of Medical Sciences
City
Shiraz
Postal code
7193616641
Phone
+98 31 4524 8966
Fax
Email
dr.s.pourseirafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)