comparison of two suture and vertical dome division(VDD) techniques in refinement of bulbous nose deformity in 70 patients that refer to the imam Khomeini hospital of Ahvaz for rhinoplasty from September 2009 to March 2010.
(1) Objectives: The term of bulbous nose refers to patients that Seems to flatten the tip of the nose. Different surgical techniques are available to improve bulbousity of nasal tip such as suturing and vertical dome division. The aim of this study was evaluation of short and long term effects of these two techniques and compare of those results to refinement of bulbous nose deformity.
(2) Design: In this study, seventy patients with bulbous nose deformity referred to the rhinoplasty done to Imam Khomeini Hospital in Ahvaz between the beginning of September 2009 to March 2010 were enrolled.
(3) Setting and conduct: Patients were divided into two equal groups of 35 patients ( group A and B ).
(4) Participants including major eligibility criteria: Patient inclusion criteria are bulbous nose deformity, Exclusion criteria included any history of previous surgery is septorhinoplasty.
(5) Intervention: patients in group A with suture and group B with vertical dome division technique underwent rhinoplasty surgery.
(6) main outcome measures (variables): in two time, respectively, a week, and then eight months after surgery for evaluation of these two surgical procedures to correction of bulbous nose deformity, were followed up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108137315N1
Registration date:2011-09-06, 1390/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-06, 1390/06/15
Registrant information
Name
Fereydoon Eslamijoo
Name of organization / entity
Vice chancellor for research, Ahwaz Jondi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 4028
Email address
eslamijoo.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Because these two techniques routinely used for these patients The cost of the surgery the patient was responsible and other expenses of the business and the type of reproduction is paid by Vice chancellor for research, Ahwaz Jondi Shapur University of Medical Sciences.
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of two suture and vertical dome division(VDD) techniques in refinement of bulbous nose deformity in 70 patients that refer to the imam Khomeini hospital of Ahvaz for rhinoplasty from September 2009 to March 2010.
Public title
Comparing two surgical techniques in Rhinoplasty
Purpose
Other
Inclusion/Exclusion criteria
Patient inclusion criteria are bulbous nose deformity؛ Exclusion criteria included any history of previous surgery is septorhinoplasty.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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
University Ethics Committee of Ahwaz Jondi Shapur University of Medical Sciences-Department of Resea
Street address
Department of Research and Technology, Jondi Shapur University of Medical Sciences, Ahwaz
City
Ahwaz
Postal code
6135715794
Approval date
2010-02-20, 1388/12/01
Ethics committee reference number
31//20/8/پ
Health conditions studied
1
Description of health condition studied
Bulbous nose deformity
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Widening of nasal tip
Timepoint
One week after surgery and eight months after surgery
Method of measurement
Measurement between two defining points of nasal tip by the ruler for surgery
Secondary outcomes
1
Description
Overnarrowing in nasal tip
Timepoint
A week after surgery and eight months after surgery
Method of measurement
Measurement between two defining points of nasal tip by the ruler for surgery
2
Description
Collapse of Lower lateral cartilages
Timepoint
A week after surgery and eight months after surgery
Method of measurement
direct visualization
Intervention groups
1
Description
Suture is a non-destructive method and helps maintain the context and integrated structure of cartilage which is helpful in formation of the tip and vestibule. Using this way, each side of the dome can be narrowed down to a limited extent and as a result the tip can also be narrowed down to a certain level.
Category
Treatment - Surgery
2
Description
VDD Method is destructive and as a result cartilage scaffold gets damaged and elasticity characteristic of the cartilage is lost in the place where it is cut. However, using this technique more severe changes in the tip can be made and reduce the width of the tip more.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Fereydoon Eslamijoo
Street address
Ear, nose and throat department, Imam Khomeini Hospital, Ahwaz
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz Jondi Shapur University of Medical Sciences
Full name of responsible person
Dr. Azardokht Khosravi
Street address
Vice chancellor for research, Jondi Shapur University of Medical Sciences, Ahwaz
City
Ahwaz
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, Ahwaz Jondi Shapur 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
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Fereydoon Eslamijoo
Position
Resident of ear, nose and throat
Other areas of specialty/work
Street address
Ear, nose and throat department, Imam Khomeini Hospital, Ahwaz.
City
Ahwaz
Postal code
Phone
+98 912 378 6095
Fax
Email
dr.f.eslami@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ear, nose and throat department, Imam Khomeini Hospital, Ahwaz.
Full name of responsible person
Dr.Ali Ghazipour
Position
Otolaryngologist, Assistant professor of otolaryngology, head and neck surgery.
Other areas of specialty/work
Street address
Ear, nose and throat department, Imam Khomeini Hospital, Ahwaz.
City
Ahwaz
Postal code
Phone
+98 916 111 0248
Fax
Email
Sorena_sf@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Imam Khomeini Hospital of Ahwaz
Full name of responsible person
Fereydoon Eslamijoo
Position
Resident of ear, nose and throat
Other areas of specialty/work
Street address
Ear, nose and throat department, Imam Khomeini Hospital, Ahwaz.
City
Ahwaz
Postal code
Phone
Fax
Email
dr.f.eslami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)