Evaluating the effectiveness of the modified lateral crural strut graft on the aesthetic indices of the nasal tip in rhinoplasty
Design
Pre- and post-intervention clinical trial, non-randomized, not blind
Settings and conduct
Thirty patients who referred to the ENT ward of Amir Alam hospital for septorhinoplasty operation were selected and divided into two groups of crural strut graft with classic method; and crural strut graft with modified method group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who undergo rhinoplasty for the first time; adult over 18 years old; Patients with parenthesis tip deformities;
Exclusion criteria: Patients with immunological and metabolic diseases; Patient dissatisfaction; Pre and post-photography in two different ateliers; Failure to refer for photographing; Patients with cleft lip and plate
Intervention groups
The Intervention group 1: Patients with crural strut graft with classic method;
The Intervention group 2: Patients with crural strut graft with modified method
Main outcome variables
Nasal tip in rhinoplasty; Tip bifidity; Double break; Supra tip break; Tip width to nasal width
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009039N6
Registration date:2019-12-23, 1398/10/02
Registration timing:retrospective
Last update:2019-12-23, 1398/10/02
Update count:0
Registration date
2019-12-23, 1398/10/02
Registrant information
Name
Shahin Bastaninezhad
Name of organization / entity
Dep. ENT, AmirAlam Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6676 0269
Email address
shahinbastani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of the modified lateral crural strut graft on the aesthetic indices of the nasal tip in rhinoplasty
Public title
Evaluating the effectiveness of the modified graft on the aesthetic indices of the nasal tip
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo rhinoplasty for the first time
Adult over 18 years old
Patients with parenthesis tip deformities.
Exclusion criteria:
Patients with immunological and metabolic diseases
Patient dissatisfaction
Pre and post photoography in two different studios
Failure to refer to the photographer
Patients with cleft lip and plate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization type is blocked randomization. Foursquare blocks of intervention group(A) and control(B) are defined on cards 1-6 (AABB,ABAB,ABBA,BBAA,BABA,BAAB), the cards are placed inside the envelope. Then the cards are selected randomly and then the random string is created from the sequence of selected cards. Patients in the intervention and control group are included in the study according to this sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
None of the participants and researchers will be aware of the allocation of groups.
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
Vice chancellor for research, Tehran University of Medical Sciences, Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-08-02, 1398/05/11
Ethics committee reference number
IR.TUMS.VCR.REC.1398.453
Health conditions studied
1
Description of health condition studied
rhinoplasty
ICD-10 code
R84
ICD-10 code description
Abnormal findings in specimens from respiratory organs and thorax
Primary outcomes
1
Description
tip plasty
Timepoint
6 months after surgery
Method of measurement
Photography before and after surgery
Secondary outcomes
1
Description
Tip bifidity
Timepoint
6 months after surgery
Method of measurement
Photography before and after surgery
2
Description
Double break
Timepoint
6 months after surgery
Method of measurement
Photography before and after surgery
3
Description
Supra tip break
Timepoint
6 months after surgery
Method of measurement
Photography before and after surgery
4
Description
Tip width to nasal width
Timepoint
6 months after surgery
Method of measurement
Photography before and after surgery
Intervention groups
1
Description
The intervention group: Under the dome and inferior border of lower lateral cartilage is dissected, modified strut cartilage will be fixed under the dome and inferior border of lower cartilage. At the end of the surgery it will be then repositioned into the rim of the pocket. With this approach after the transdomal suture the subdomal graft will help in new dome shaping. Therefore, the additional length will help in firming and ideal forming of alas.
Category
Treatment - Surgery
2
Description
Control group: In this group the usual method of tip plasty will be performed and only the inferior border of lower lateral cartilage will dissected and the usual graft will be fixed under the lower, the lateral part of graft will be positioned in the pocket of rim to maintain the stability of the rim.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
AmirAlam hospital
Full name of responsible person
Hakima Abdullah
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 6108
Email
dr.haabdullah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadali Sahraeian
Street address
Ghods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
resdeputy@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Hakima Abdullah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 8103
Email
dr.haabdullah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Bastaninejad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 3037
Fax
+98 21 6676 0269
Email
shahinbastani@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hakima Abdullah
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
North Saadi St, AmirAlam Hospital
City
Tehran
Province
Tehran
Postal code
1145765111
Phone
+98 21 6670 3037
Email
dr.haabdullah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available