Comparison of obtaining and maintaining nasal tip projection between columellar strut and posterior strut methods in patients referred to Bahonar hospital
Design
A randomized triple-blind clinical trial with a control group. The study design includes two parallel groups in the 3rd phase each including 10 patients. According to the table of random numbers, patients are classified into two groups.
Settings and conduct
This study will be conducted in the maxillofacial surgery department of Bahoner Hospital, Kerman. Candidate rhinoplasty patients will be randomly divided into two groups: posterior strut and columellar strut. Patients are not aware of which treatment they are receiving. Also, the outcome assessor will not be aware. The main variable will include the nasal tip projection.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. All adult patients candidates for rhinoplasty
2. ASA class I, II
3. Age range between 18 and 40 years
4. Complete the informed consent
Exclusion criteria:
1.Patients who do not want to continue attending and participating in this study for any reason
Intervention groups
Patients are divided into two groups, one group will undergo columellar strut operation and the other group will undergo posterior strut operation.
Main outcome variables
The investigated variables include age, gender, operation length, and the amount of nasal tip projection. The mentioned variables will be measured before and after the operation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240517061819N1
Registration date:2024-06-18, 1403/03/29
Registration timing:prospective
Last update:2024-06-18, 1403/03/29
Update count:0
Registration date
2024-06-18, 1403/03/29
Registrant information
Name
Ali Labafchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3551 1852
Email address
a.labafchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-02-18, 1403/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of nasal tip projection between columellar strut and posterior strut methods
Public title
Comparison of nasal tip projection between columellar strut and posterior strut methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with nose deformity who are candidates for Rhinoplasty
Patients between the ages of 18 and 40
Patients who have completed the informed consent
Exclusion criteria:
Patients who do not want to continue attending and participating in this study for any reason
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Since the two groups are supposed to have the same sample size, Patients eligible for inclusion will be divided into 2 groups using the Blocked Randomization method by one of the nurses of the relevant ward, who is not aware of the implementation of the study. Random sequences will be generated using the Random Generator program. Random allocation concealment will be done using sequentially numbered, sealed, opaque envelopes by an independent person who does not know the study process.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, outcome assessor, and statistical analyzer will not be aware of the study groups. Regarding patients, blinding is so that patients will not know with which method the surgery will be performed. Regarding the assessor, the operator who completed the study checklist is not aware of the group assignment. The statistical analyzer will be blinded and all data will be provided in the form of coding to him.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
University campus, Haftbagh Square, shahab st.
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.KMU.REC.1402.419
Health conditions studied
1
Description of health condition studied
Nose deformity
ICD-10 code
M95.0
ICD-10 code description
Acquired deformity of nose
Primary outcomes
1
Description
Nasal tip projection
Timepoint
3 month after surgery
Method of measurement
Goode’s method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the tip of the patients' nose will be operated with the posterior strut method.
Category
Treatment - Surgery
2
Description
Control group: the tip of the patients' nose will be operated with the columellar strut method.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar hospital, kerman
Full name of responsible person
Kianosh Mobasseri
Street address
Bahonar hospital, Gharani st.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kianooshmobasseri@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abedin Iranpour
Street address
University of Medical Sciences campus, Haft Bagh Alavi Blvd., Kerman,
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
a.iranpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Kianosh Mobasseri
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar hospital, gharani Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kianooshmobasseri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kianosh Mobasseri
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar hospital, gharani Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kianooshmobasseri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kianosh Mobasseri
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Bahonar hospital, gharani Blvd.
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
kianooshmobasseri@gmail.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
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
All collected data would be shared for all researchers after the participants were unidentified.
When the data will become available and for how long
The access to data will be started 6 months after publication
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding research.
Email: kianooshmobasseri@gmail.com
What processes are involved for a request to access data/document
The new research proposal and the processes details should be e-mailed to corresponding researcher in order to get the access permission