Protocol summary
-
Study aim
-
Improving the outcome of rhinoplasty surgery
-
Design
-
Double-blind, randomized clinical trial with a control group. A study on 70 patients who were randomly divided into two groups
-
Settings and conduct
-
Patients with thick skin in the nasal area after cosmetic surgery are not completely satisfied with the result of the operation, but with this method. This includes thinning the skin at the tip of the nose, which may improve patient satisfaction. The study is performed on patients in Isfahan hospitals. Patients are randomly divided into two groups, in one group the intervention and in the control group the intervention is not performed to thin the skin.
-
Participants/Inclusion and exclusion criteria
-
Admission requirements: Minimum age 18, Candidate for rhinoplasty surgery, Thick nasal skin, Informed consent. Exclusion criteria: history of rhinoplasty, history of smoking
-
Intervention groups
-
Patients in the control group are operated as usual ، and the intervention group is operated by removing adipose tissue and muscle behind the skin of the tip of the nose.
-
Main outcome variables
-
Variables include skin thickness, postoperative satisfaction, and complications such as bleeding, skin necrosis, edema, scarring, and postoperative infection.
General information
-
Reason for update
-
An update was performed to complete the last patient visit.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210921052537N1
Registration date:
2021-10-30, 1400/08/08
Registration timing:
retrospective
Last update:
2022-01-27, 1400/11/07
Update count:
1
-
Registration date
-
2021-10-30, 1400/08/08
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-11-01, 1400/08/10
-
Expected recruitment end date
-
2021-12-01, 1400/09/10
-
Actual recruitment start date
-
2021-09-23, 1400/07/01
-
Actual recruitment end date
-
2021-10-12, 1400/07/20
-
Trial completion date
-
2022-01-27, 1400/11/07
-
Scientific title
-
Evaluation of clinical outcomes and satisfaction of rhinoplasty with or without SMASectomy with the aim of thinning the nasal tip in patients with thick nasal skin
-
Public title
-
Evaluation of the effect of thinning of the tip of the nose on rhinoplasty in patients with thick skin
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients who come for rhinoplasty
Patients have thick nasal skin
Patients are at least 18 years old
Patients who have given informed consent
Exclusion criteria:
Those who smoke
Those who have a history of rhinoplasty
-
Age
-
From 18 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
70
Actual sample size reached:
70
-
Randomization (investigator's opinion)
-
N/A
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Patients who go for rhinoplasty and have thick skin are divided into two groups by permuted block randomization method and the patient does not know the type of operation. After the operation, the result is examined by four groups, the beautician, the patient, the cosmetic nurse, and another plastic surgeon who does not know the type of operation.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-09-19, 1400/06/28
-
Ethics committee reference number
-
IR.MUI.MED.REC.1400.491
Health conditions studied
1
-
Description of health condition studied
-
Rhinoplasty
-
ICD-10 code
-
Z41.1
-
ICD-10 code description
-
Encounter for cosmetic surgery
Primary outcomes
1
-
Description
-
Postoperative satisfaction
-
Timepoint
-
1, 3 and 6 months after surgery
-
Method of measurement
-
Satisfaction questionnaire,Photograph and collis
Secondary outcomes
1
-
Description
-
Bleeding
-
Timepoint
-
1, 3 and 6 months after surgery
-
Method of measurement
-
Patient examination and photo
2
-
Description
-
Edema
-
Timepoint
-
1, 3 and 6 months after surgery
-
Method of measurement
-
Patient examination ، photo and collis
3
-
Description
-
Scare
-
Timepoint
-
1, 3 and 6 months after surgery
-
Method of measurement
-
Patient examination and photo
4
-
Description
-
Necrosis
-
Timepoint
-
1, 3 and 6 months after surgery
-
Method of measurement
-
Patient examination and photo
Intervention groups
1
-
Description
-
Intervention group: The skin of the tip of the nose Patients becomes thin during rhinoplasty
-
Category
-
Treatment - Surgery
2
-
Description
-
Control group: Patients undergo rhinoplasty without thinning the skin at the tip of the nose
-
Category
-
Treatment - Surgery
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan 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
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
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available
-
Title and more details about the data/document
-
A clinical trial report will be available for subscription, including gender, age, procedure, and postoperative information for each individual and postoperative outcome.
-
When the data will become available and for how long
-
Start access one year after the results are published
-
To whom data/document is available
-
Clinical study reports are only available to plastic surgeons
-
Under which criteria data/document could be used
-
Using reports from clinical studies to conduct research on rhinoplasty techniques can be used by citing the source.
-
From where data/document is obtainable
-
Esmaeil Talebian ,email: drtalebian@yahoo.com
-
What processes are involved for a request to access data/document
-
The applicant will receive a clinical study report after sending an email and explaining the reason for the need for the data, and future research of the applicant, after 10 days the information will be sent to him by email.
-
Comments
-