Comparison between Nylon and PDS suture for development and maintenance of rotation and projection in Tongue-in-groove technique rhinoplasty on rhinoplasty patients
Determine difference between Nylon vs PDS Suture in Tongue-In-Groove technique in development and maintenance of nasal tip projection and rotation in Rhinoplasty
Design
In this block-randomized double-blind clinical trial, 64 randomly-selected patients were randomized to receive PDS (n=22) or nylon (n=29) suture material (both 0-5) in tongue in groove technique.The blocks were developed by epidemiologist with one code for each patient was considered to assign in A or B group. It was only known by epidemiologist and the surgeon was blind till TIG operation and also patients and minor researchers were blind
Settings and conduct
The standard image before and after (in months 1, 6, and 12) was prepared and the projection and rotation was determined by Photoshop software via Goode’s method and nasolabial angle was measured.The satisfaction rate from rhinoplasty procedure was determined by Visual analogue scale (VAS) in 1,6,and 12 months after. The nasal function was measured by Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) scale before and 1 year after surgery.The skin thickness and septal deviation were recorded by preoperative physical examination and also the remained lateral crura were measured by caliper
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients who were enrolled for External incision Rhinoplasty and Tongue in Groove technique was possible to
Exclusion Criteria:congenital anomalies;severe septal deviation;severe nasal bone deviation;hypersensitivity to suture materials;revision surgery
Intervention groups
Intervention group 1: using Nylon 5-0 Suture in TIG Technique
Intervention group 2: using PDS 5-0 Suture in TIG Technique
Main outcome variables
Nasal Tip Projection;Nasal Tip Rotation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080820001056N4
Registration date:2020-03-12, 1398/12/22
Registration timing:retrospective
Last update:2020-03-12, 1398/12/22
Update count:0
Registration date
2020-03-12, 1398/12/22
Registrant information
Name
babak saedi
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 2270 0765
Email address
saedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2018-02-04, 1396/11/15
Actual recruitment start date
2017-10-02, 1396/07/10
Actual recruitment end date
2018-02-04, 1396/11/15
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Comparison between Nylon and PDS suture for development and maintenance of rotation and projection in Tongue-in-groove technique rhinoplasty on rhinoplasty patients
Public title
comparison between Nylon versus PDS in Tongue-in-groove technique in rhinoplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients enrolled in open rhinoplasty and it was possible to perform TIG
Exclusion criteria:
congenital anomalies
severe septal deviation
severe nasal bone deviation
hypersensitivity to material used in surgery
revision surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
64
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
with block randomization of size 4 ,the patients were placed in 2 groups of A and B.In one group Nylon suture and in other group PDS suture was uesd.The blocks were developed by epidemiologist with one code for each patient was considered to assign in A or B group
Blinding (investigator's opinion)
Double blinded
Blinding description
The epidemiologist was the only person who knows randomization code. The surgeon will not know about the suture material types until the end of surgery. The surgeon assistant will let him know suture material types at the end of surgery during TIG. The surgeon assistant will be blinded about suture material before surgery and patients won't know suture materials were used during their surgeries.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Tehran University of Medical Sciences
Street address
No 1068,First Enterance,Block 5,Ekbatan town
City
tehran
Province
Tehran
Postal code
1396843193
Approval date
2017-09-26, 1396/07/04
Ethics committee reference number
IR.TUMS.VCR.REC.1396.3571
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nasal tip projection
Timepoint
Nasal tip projection measurements before intervention and 1,6,12 months after intervention
Method of measurement
Goode's ratio
2
Description
Nasal tip rotation
Timepoint
Nasal tip rotation measurements before intervention and 1,6,12 months after intervention
Method of measurement
nasolabial angle
Secondary outcomes
1
Description
Patient's Satisfaction of Rhinoplasty
Timepoint
1,6,and 12 months after surgery
Method of measurement
Visual Analogue Scale(VAS)
2
Description
Nasal Function
Timepoint
Before and 1 year after surgery
Method of measurement
Standardized Cosmesis and Health Nasal Outcomes Survey (SCHNOS) scale
Intervention groups
1
Description
Intervention group 1: using Nylon 5-0 Suture(ethicon company) in TIG Technique. only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS
Category
Treatment - Surgery
2
Description
Intervention group: 2 ,using PDS 5-0 Suture( ethicon company). in TIG Technique.only one suture was used.Nasal tip projection measurements by Goode's ratio method and Nasal tip rotation measurements by nasolabial angel is done before intervention visit and 1,6,12 months after intervention visit by performing standard photography and photo analysis with photoshop .also checking the Patient's Satisfaction of Rhinoplasty by Visual Analogue Scale in visits of 1,6,12 months after intervention and checking nasal function before intervention visit and 12 months after intervention visit with SCHNOS
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Babak Saedi
Street address
Keshavarz Blvd Ghods avenu Tehran University
City
Tehran
Province
Tehran
Postal code
141979733141
Phone
+98 21 6658 1628
Email
saedi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Sahrain
Street address
Vice Chancellor for Research,Centarl Office of Tehran University of Medical Science,Qods ave,Keshavarz blv
City
tehran
Province
Tehran
Postal code
141979733141
Phone
+98 21 8163 3619
Email
rmo@tums.ac.ir
Grant name
Vice Chancellor for Research Tehran University of Medical sciences
Grant code / Reference number
9411369010
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Babak Saedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Keshavars BLV ,Imama khomainee hospital
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
Fax
+98 21 6658 1628
Email
saedi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Babak saedi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Keshavars BLV ,Imam khomainee Hospital
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 2270 0765
Fax
+98 21 6658 1628
Email
saedi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahand Kia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
No 1068,First Enterance,Block 5,Ekbatan city
City
Tehran
Province
Tehran
Postal code
1396843193
Phone
+98 21 4469 4274
Email
kia.sahand@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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
we will publish it in article
When the data will become available and for how long
we will publish it in article 2020
To whom data/document is available
nobody can have anything more than article
Under which criteria data/document could be used
we will publish it article but nobody can have access to other data
From where data/document is obtainable
we will publish it in article
What processes are involved for a request to access data/document