Correction of deviated nose by using dynamic adjustable tip graft
Design
Patients 18 to 40 years, Single group' clinical trial, 18 patients with nose deviated
Settings and conduct
This research was conducted in Besat Hospital of Hamadan. First, a close-up photo of the face is taken from different angles. The dorsal angle is measured and recorded from taken photo-graphics by measuring the angle created between the two hypothetical lines: mid line and dorsal aesthetic line as well as the angle of the tip of the nose. In this study, open rhinoplasty is performed by inverted gull wing incision in all patients. After lifting the flap and exposing the dorsum and lifting the mucosal flap of the submucosa and sub mucoperichondrium through the septum and humpectomy, the L-strut is preserved and the quadrangular cartilage is removed. After performing the required rhinoplasty procedures in each patient, two long spreader grafts are placed on both sides of the septum and fixed to the medial crura on both sides and the columella strut, in all of them, thus creating a dynamic adjustable rotational tip garaft. After the end of the surgery, the patients are followed up for two years and at the end of the second year, a close-up graph is taken and the mentioned indicators are re-evaluated.
Participants/Inclusion and exclusion criteria
Patients with deviation; Age 18 to 40 years
Medical diseases that prevent surgery; History of previous surgery on the nose and face; Patient dissatisfaction
Intervention groups
Rhinoplasty to treat nose deviated
Main outcome variables
nose deviation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180531039923N1
Registration date:2020-07-23, 1399/05/02
Registration timing:retrospective
Last update:2020-07-23, 1399/05/02
Update count:0
Registration date
2020-07-23, 1399/05/02
Registrant information
Name
Elnaz Shariatpanahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3264 3069
Email address
e.shariatpanahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-04-09, 1398/01/20
Actual recruitment end date
2020-03-15, 1398/12/25
Trial completion date
2020-03-15, 1398/12/25
Scientific title
Correction of deviated nose by using dynamic adjustable tip graft
Public title
deviated nose by using dynamic adjustable tip graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with deviation
deviation
Age 18 to 40 years
Exclusion criteria:
Medical diseases that prevent surgery
- History of previous surgery on the nose and face
Patients' dissatisfaction
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
18
Actual sample size reached:
18
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Ethics Committee in Research, Office of Vice Chancellor for Education, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan.
City
hamadan
Province
Hamadan
Postal code
65176-19657
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.UMSHA.REC.1398.1061
Health conditions studied
1
Description of health condition studied
deviation
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Feeling of inability of the patient to enter and exit the air from the nasal vestibule
Timepoint
Photographs are taken before and two years after surgery.
Method of measurement
The Dorsum angle is measured, The Nasal tip angle is measured
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, open rhinoplasty is performed by inverted gull wing incision in all patients. After lifting the flap and exposing the dorsum and lifting the mucosal flap of the submucosa and sub mucoperichondrium through the septum and humpectomy, the L-strut is preserved and the quadrangular cartilage is removed. After performing the required rhinoplasty procedures in each patient, two long spreader grafts are placed on both sides of the septum and fixed to the medial crura on both sides and the columella strut, in all of them, thus creating a dynamic adjustable rotational tip garaft.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Elnaz Shariatpanahi
Street address
Next to ENT Clinic, Besat Hospital, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0021
Email
e.shariatpanahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Office of Vice Chancellor for Education, Hamedan University of Medical Sciences , Shahid Fahmideh Blvd, Hamadan.
City
Hamadan
Province
Hamadan
Postal code
6517619657
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
internationalaffairs@umsha.ac.ir
Web page address
http://en.umsha.ac.ir/?p=289
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
Elnaz Shariatpanahi
Position
Assistant Professor, Faculty member of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Next to ENT Clinic, Besat Hospital, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0021
Fax
Email
e.shariatpanahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elnaz Shariatpanahi
Position
Assistant Professor, Faculty member of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Next to ENT Clinic, Besat Hospital, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0021
Fax
+98 81 3265 1515
Email
e.shariatpanahi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elnaz Shariatpanahi
Position
Assistant Professor, Faculty member of Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Next to ENT Clinic, Besat Hospital, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0021
Email
e.shariatpanahi@yahoo.com
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about back angle, tip angle, nasal obstruction, before and after surgery is shared
When the data will become available and for how long
It is possible to start accessing the information 3 months after the results are published
To whom data/document is available
ENT researchers
Under which criteria data/document could be used
The output of the researchers should not be the same as our article data
From where data/document is obtainable
Email to: e.shariatpanahi@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, if the requested information is available, the items will be emailed to the person within a maximum of one week