Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
Design
A randomized double-blind clinical trial study with a control group, with parallel design on 80 patients. Block randomization method will be used for randomization.
Settings and conduct
Khalili and Ghadir Mother and Child hospital affiliated to Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: age> 18 years, patients with primary surgery, absence of systemic and dermatologic diseases.
Exclusion criteria: if they did not returned follow-up visit after 12 months or had previous scar in site of alarplasty with any reasons.
Intervention groups
first group: patients who underwent Serdev suturing technique.
second group: patients who underwent alar wedge excision suturing technique.
Main outcome variables
Duration of procedure; amount of bleeding; need for bleeding control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131020015083N2
Registration date:2021-11-20, 1400/08/29
Registration timing:retrospective
Last update:2021-11-20, 1400/08/29
Update count:1
Registration date
2021-11-20, 1400/08/29
Registrant information
Name
Amir Hossein Babaei
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 739 5073
Email address
babaei@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
Public title
Comparing of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age> 18 years
patients with primary surgery
absence of systemic and dermatologic diseases
Exclusion criteria:
Previous scar in the site of alarplasty
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to Serdev (number 0 in select case) or external wedge resection (number 1 in select case) groups (1: 1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection.
Blinding (investigator's opinion)
Double blinded
Blinding description
Outcome assessor, Investigator and statisticians who analyzed the data were unaware of the intervention and allocation of treatments until the statistical analysis was complete.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.SUMS.MED.REC.1399.064
Health conditions studied
1
Description of health condition studied
patients with large alar base
ICD-10 code
Z41.1
ICD-10 code description
Encounter for cosmetic surgery
Primary outcomes
1
Description
amount of bleeding
Timepoint
intra-operative
Method of measurement
volume of bleeding (CC)
2
Description
duration of procedure
Timepoint
intra-operative
Method of measurement
digital chronometer (min)
3
Description
need for bleeding control
Timepoint
intra-operative
Method of measurement
using electrocautery to stop bleeding
Secondary outcomes
1
Description
scar formation
Timepoint
12 months after surgery
Method of measurement
direct examination
2
Description
satisfaction score
Timepoint
12 months after surgery
Method of measurement
ROE and PSAQ questionnaire
Intervention groups
1
Description
Intervention group: Serdev suturing technique
Category
Treatment - Surgery
2
Description
Control group: External wedge resection
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ear, Nose and Throat Clinic, Khalili Hospital
Full name of responsible person
Dr Reza Kaboodkhani
Street address
khalili street
City
shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Fax
Email
kaboodkhani@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Mother and Child Hospital
Full name of responsible person
Dr Reza Kaboodkhani
Street address
Quran gate
City
shiraz
Province
Fars
Postal code
7144995377
Phone
+98 71 3227 9701
Fax
Email
kaboodkhani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaeianzadeh
Street address
zand street
City
shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
98-01-01-21228
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Reza Kaboodkhani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
khalili street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
kaboodkhani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nooshin Naderi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Khalili street
City
Shiraz
Province
Fars
Postal code
7193636981
Phone
+98 71 3629 1470
Email
nooshinnaderi1369@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Amirhossein Babaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Zand blvd, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7196741475
Phone
+98 917 739 5073
Fax
Email
babaei@sums.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
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
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
Title and more details about the data/document
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions.
What processes are involved for a request to access data/document
the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email.