To determine the results of septo-rhinoplasty treatment using the modified swing door technique
Design
Clinical trial without control group, without randomization and as a before and after trial
Settings and conduct
In this study, all rhinoplasty surgeries are performed under general anesthesia and the open surgical technique is used for better access to the septum. Septoplasty is performed with the introduced technique.
After the tip plasty, osteotomy is performed externally.
An intranasal splint is used for one week. Extranasal splint remains in the area for one week. Three months after the surgery, photographs are taken of the patients.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this study include adult patients over 18 years of age with nasal deformity and deviation in the septum who are applying for rhinoplasty, who are not suffering from cancer, do not have diabetes, cardiovascular problems, and immune system deficiency. Patients with a history of previous rhinoplasty are excluded from the study.
Intervention groups
First, photographs are taken of the patients before the operation. Septoplasty is performed by a surgeon with a new method on patients. An intranasal splint is used for one week. Extranasal splint remains in the area for one week. Three months after the surgery, photographs are taken of the patients.
The results are reported using three MiRa tools, ROE ranking and anthropometric evaluation.
Main outcome variables
The level of patient satisfaction with the MiRa tool, ROE rating and anthropometric evaluation on post-operative photography within 3 months of rhinoplasty surgery is measured.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230812059129N1
Registration date:2023-10-02, 1402/07/10
Registration timing:retrospective
Last update:2023-10-02, 1402/07/10
Update count:0
Registration date
2023-10-02, 1402/07/10
Registrant information
Name
Mehdi Heidarizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 032 9564
Email address
heidarizadeh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-20, 1402/05/29
Expected recruitment end date
2023-09-20, 1402/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of results following septorhinoplasty with modified swing door (before and after clinical trial)
Public title
comparison of results following septorhinoplasty with modified swing door (before and after clinical trial)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients over 18 years old
Suffering from nasal deformity and deviation in the septum
Rhinoplasty applicant
No cancer
The absence of diabetes, cardiovascular problems and immune system defects
Exclusion criteria:
History of previous rhinoplasty
Age
From 18 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
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Sardasht
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.ARAKMU.REC.1402.102
Health conditions studied
1
Description of health condition studied
nasal septal deviation
ICD-10 code
J34.2
ICD-10 code description
Deviated nasal septum
Primary outcomes
1
Description
Objective comparison of angles with deviation of anthropometric parameters
Timepoint
3-months after surgery
Method of measurement
Face photographs
2
Description
Evaluation of nasal deformity before and after septorhinoplasty
Timepoint
3-months after surgery
Method of measurement
MiRa standard scale
3
Description
Evaluation of patient satisfaction after septorhinoplasty
Timepoint
3-months after surgery
Method of measurement
Rhinoplasty Outcome Evaluation (ROE) scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, photographs are taken of the patients before the operation. Septoplasty is performed by a surgeon on patients with a new method. In this technique, all rhinoplasty surgeries are performed under general anesthesia and open surgery technique is used for better access to the septum. The skin flap of the dorsum of the nose is raised. In the midline, the middle and medial domes and coruras as well as the upper lateral cartilages are separated from the septum and an excellent access to the septum is achieved. Submucoperichondral flaps are raised bilaterally. In patients with cartilaginous or bony hump, the bony hump is removed with the help of a rasp and the cartilaginous hump is removed with a No. 15 blade. l-strut is prepared with a No. 15 blade so that its caudal edge is at a distance of ten mm from the caudal edge of the septum and its lateral edge is at a distance of 20 mm from the lateral edge of the septum. The cartilaginous clamp is harvested from the caudal part of the dorsal incision and in the vicinity of the bony septum. Then, an incision is made parallel to the transverse surface of the septum and at a distance of 10 mm from it, from the caudal septum (Heidarizadeh incision), which determines the length of this incision, the location and the amount of deviation of the septum. The cartilage clamp harvested in the previous stage is placed vertically between the two horizontal parts created as a result of Heidarizadeh incision, without any additional maneuvers, and separates the two parts of the septum in the area of the tip of the nose like a wedge. The cephalocaudal position of this grip is also dependent on the severity of the deviation and the amount of correction required. For the plastic type, after cephalic resection, transdome and interdome sutures are applied; The columellar strut is placed, and then a 2mm thick and 7mm wide cap is placed in the area of the dome (the distance between the tip defining points). Finally, diced cartilage is placed and osteotomy is performed externally. If needed, alarplasty is performed in the usual way by resection of a wedge-like area and the area is sutured with 0-6 nylon thread. An intranasal splint is used for one week. Extranasal splint remains in the area for one week. Three months after the surgery, photographs are taken of the patients.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dey limited surgery center
Full name of responsible person
Mehdi Heidarizadeh
Street address
Shahid Shiroodi
City
Arak
Province
Markazi
Postal code
3819737447
Phone
+98 912 032 9564
Email
heidarizadeh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Davood Hekmatpoo
Street address
sardasht
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
-
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
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
School of dentistry, Arak University of Medical Sciences, in front of Madar park, Golestan Quarter, Mostafa Khomeini st.
City
Arak
Province
Markazi
Postal code
3819737447
Phone
+98 912 032 9564
Fax
Email
heidarizadeh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Arak University of Medical Sciences, in front of Madar park, Golestan Quarter, Mostafa Khomeini st.
City
Arak
Province
Markazi
Postal code
3819737447
Phone
+98 912 032 9564
Fax
Email
heidarizadeh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Heidarizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of dentistry, Arak University of Medical Sciences, in front of Madar park, Golestan Quarter, Mostafa Khomeini st.
City
Arak
Province
Markazi
Postal code
3819737447
Phone
+98 912 032 9564
Fax
Email
heidarizadeh@ajums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of analyzes and data of each patient are accessible
When the data will become available and for how long
A year after the publication of the article
To whom data/document is available
Academic researchers and reviewers of medical journals
Under which criteria data/document could be used
Any analysis on the data of each patient is allowed, but it should be done by referees of medical journals
From where data/document is obtainable
The author and journal published the article
What processes are involved for a request to access data/document
The email will be given to the author or the publishing journal and the information will be sent shortly.