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Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery

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History
# Registration date Revision Id
2 2022-02-01, 1400/11/12 215716
1 2021-11-20, 1400/08/29 206036
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  • Protocol summary

    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.
    A randomized single-blind clinical trial study with a control group, with parallel design on 80 patients. Block randomization method will be used for randomization.
    مطالعه کارآزمایی بالینی دو سوکور تصادفی سازی شده دارای گروه کنترل، با گروه های موازی بر روی 80 نفر بیمار. جهت تصادفی سازی از روش بلوک های تصادفی استفاده خواهد شد.
    مطالعه کارآزمایی بالینی یک سوکور تصادفی سازی شده دارای گروه کنترل، با گروه های موازی بر روی 80 نفر بیمار. جهت تصادفی سازی از روش بلوک های تصادفی استفاده خواهد شد.
    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.
    Inclusion criteria: age> 18 years, patients with primary surgery, absence of systemic and dermatologic diseases. Exclusion criteria: if patients did not returned follow-up visit after 12 months or had previous scar in site of alarplasty with any reasons.
    first group: patients who underwent Serdev suturing technique. second group: patients who underwent alar wedge excision suturing technique.
    First group: patients who underwent Serdev suturing technique. Second group: patients who underwent alar wedge excision technique.

  • General information

    Double blinded
    Single blinded
    empty
    Primary and secondary outcomes were entered instead of each other that corrected. Also, the study is single-blind because the patients were not blind.
    empty
    پیامد های اولیه و ثانویه در زمان ثبت کلینیکال تریال جابه جا وارد شده بود که اصلاح گردید. همچنین مطالعه به علت بلایند نبودن بیماران، single blind می باشد.
    age> 18 years
    patients with primary surgery
    absence of systemic and dermatologic diseases
    Age> 18 years
    Patients with primary surgery
    Absence of systemic and dermatologic diseases

  • Primary outcomes

    #1
    amount of bleeding
    Scar formation
    میزان خونریزی حین عمل
    ایجاد اسکار
    intra-operative
    12 months after surgery
    حین عمل جراحی
    12 ماه بعد از عمل جراحی
    volume of bleeding (CC)
    Direct examination
    تعیین حجم بر اساس CC
    معاینه مستقیم بیمار
    #2
    duration of procedure
    Satisfaction score
    طول مدت عمل
    میزان رضایت بیماران
    intra-operative
    12 months after surgery
    حین عمل جراحی
    12 ماه بعد از عمل جراحی
    digital chronometer (min)
    ROE and PSAQ questionnaire
    کورنومتر دیجیتال (برحسب دقیقه)
    پرسشنامه PSAQ و ROE
    #3
    need for bleeding control
    empty
    نیاز به کنترل خونریزی
    empty
    intra-operative
    empty
    حین عمل جراحی
    empty
    using electrocautery to stop bleeding
    empty
    بند آوردن خون با دستگاه الکتروکوتری
    empty

  • Secondary outcomes

    #1
    scar formation
    Amount of bleeding
    ایجاد اسکار
    میزان خونریزی حین عمل
    12 months after surgery
    Intra-operative
    12 ماه بعد از عمل جراحی
    حین عمل جراحی
    direct examination
    Volume of bleeding (CC)
    معاینه مستقیم بیمار
    تعیین حجم بر اساس CC
    #2
    satisfaction score
    Duration of procedure
    میزان رضایت بیماران
    طول مدت عمل
    12 months after surgery
    Intra-operative
    12 ماه بعد از عمل جراحی
    حین عمل جراحی
    ROE and PSAQ questionnaire
    Digital chronometer (sec)
    پرسشنامه PSAQ و ROE
    کورنومتر دیجیتال (برحسب ثانیه)
    #3
    empty
    Need for bleeding control
    empty
    نیاز به کنترل خونریزی
    empty
    Intra-operative
    empty
    حین عمل جراحی
    empty
    Using electrocautery to stop bleeding
    empty
    بند آوردن خون با دستگاه الکتروکوتری

  • Recruitment centers

    #1
    Name of recruitment center - English: Ear, Nose and Throat Clinic, Khalili Hospital
    Name of recruitment center - Persian: بخش گوش و حلق و بینی بیمارستان خلیلی
    Full name of responsible person - English: Dr Reza Kaboodkhani
    Full name of responsible person - Persian: دکتر رضا کبودخانی
    Street address - English: khalili street
    Street address - Persian: خیابان خلیلی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7193636981
    Phone: +98 71 3629 1470
    Fax:
    Email: kaboodkhani@yahoo.com
    Web page address:
    Name of recruitment center - English: Ear, Nose and Throat Clinic, Khalili Hospital
    Name of recruitment center - Persian: بخش گوش و حلق و بینی بیمارستان خلیلی
    Full name of responsible person - English: Dr Reza Kaboodkhani
    Full name of responsible person - Persian: دکتر رضا کبودخانی
    Street address - English: khalili street
    Street address - Persian: خیابان خلیلی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7193636981
    Phone: +98 71 3629 1470
    Fax:
    Email: kaboodkhani@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Mother and Child Hospital
    Name of recruitment center - Persian: بیمارستان مادر و کودک غدیر
    Full name of responsible person - English: Dr Reza Kaboodkhani
    Full name of responsible person - Persian: دکتر رضا کبودخانی
    Street address - English: Quran gate
    Street address - Persian: دروازه قرآن
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7144995377
    Phone: +98 71 3227 9701
    Fax:
    Email: kaboodkhani@yahoo.com
    Web page address:
    Name of recruitment center - English: Mother and Child Hospital
    Name of recruitment center - Persian: بیمارستان مادر و کودک غدیر
    Full name of responsible person - English: Dr Reza Kaboodkhani
    Full name of responsible person - Persian: دکتر رضا کبودخانی
    Street address - English: Quran gate
    Street address - Persian: دروازه قرآن
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7144995377
    Phone: +98 71 3227 9701
    Fax:
    Email: kaboodkhani@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abbas Rezaeianzadeh
    Full name of responsible person - Persian: دکتر عباس رضائیان زاده
    Street address - English: zand street
    Street address - Persian: خیابان زند
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134844119
    Phone: +98 71 3235 7282
    Fax:
    Email: vcrdep@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Abbas Rezaeianzadeh
    Full name of responsible person - Persian: دکتر عباس رضائیان زاده
    Street address - English: Zand street
    Street address - Persian: خیابان زند
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134844119
    Phone: +98 71 3235 7282
    Fax:
    Email: vcrdep@sums.ac.ir
    Web page address:

Protocol summary

Study aim
Comparing the outcomes and complications of alar wedge excision and Serdev suturing techniques for alar base reduction surgery
Design
A randomized single-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 patients 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 technique.
Main outcome variables
Duration of procedure; amount of bleeding; need for bleeding control

General information

Reason for update
Primary and secondary outcomes were entered instead of each other that corrected. Also, the study is single-blind because the patients were not blind.
Acronym
IRCT registration information
IRCT registration number: IRCT20131020015083N2
Registration date: 2021-11-20, 1400/08/29
Registration timing: retrospective

Last update: 2022-02-05, 1400/11/16
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)
Single 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
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

Secondary 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 (sec)

3

Description
Need for bleeding control
Timepoint
Intra-operative
Method of measurement
Using electrocautery to stop bleeding

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.
Under which criteria data/document could be used
there is no specified criteria
From where data/document is obtainable
corresponding author (09177395073, babaei@sums.ac.ir)
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.
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