Protocol summary

Summary
1-Objectives: In this study we compare two methods which are used for the correction of tip among patients who have ptotic tip disorder. The target group of patients suffer acute nasolabial angle and columellar retraction where acute nasolabial angle refers to a nasolabial angle less than 90 degrees in men and a nasolabial angle less than 95 degrees in women, and columellar retraction is the columella size less than 3 millimeters. The study has two objectives.The first one is to compare correction ratio of nasolabial angle in two methods including "cuadal extension graft'' and ''columellar strut with plumping graft''.The second objective is to compare the amount of columella size correction achieved by these techniques.2-Design, procedure, and intervention: In this study, 74 patients participated who were 18-40 years old and admitted for open rhinoplasty. The patients were randomly divided into two groups where each group was treated with a different tip surgery method. One group was treated by "caudal extension graft'', and for the other group ''columellar strut with plumping graft" was performed. We evaluated the result of the techniques 9 months after the operations. The standard face photograph before the operation and 9 months after the operation were taken. The preoperative and the postoperative standard photographs were evaluated by a physician who was unaware of the method which was used for the treatment of the patient. The physician measured nasolabial angle and columella size. Finally, the measurement data will analyze using statistical software. 3-Variables: A)preoperation nasolabial angle؛ B)postoperation nasolabial angle؛ C)preoperation columella size؛ D)Postoperation columella size.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012102211215N1
Registration date: 2014-01-24, 1392/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-24, 1392/11/04
Registrant information
Name
Saeid Atighechi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1724 0171
Email address
atighechi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences and Health Service Mrtyr Sadoughi, vice chancellor for research
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the correction of "acute nasolabial angle" and "columellar retraction" in two methods “cuadal extension graft” and “columellar strat with plumping graft” in open rhinoplasty surgery
Public title
Comparison of the correction of "acute nasolabial angle" and "columellar retraction" in two methods “cuadal extension graft” and “columellar strat with plumping graft” in open rhinoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age group 18-40 years; nasolabial angle less than 90 degrees in male and less than 95 degrees in female; columella show less than 3 mm. Exclusion criteria: The patients disagreement; revision rhinoplasty; patients with poor coordination for fallow-up
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Shahid Sadoughi University of Medical Sciences and Health Services
Street address
The Central Organization of Medical Sciences and Health Services Martyr Sadoughi, Martyr Dr Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
p/17/1/42803

Health conditions studied

1

Description of health condition studied
Follow-up care involving plastic surgery of open rhinoplasty
ICD-10 code
Z42.0
ICD-10 code description
Follow-up care involving plastic surgery of head and neck

Primary outcomes

1

Description
Nasolabial angle
Timepoint
pre and postoperation
Method of measurement
calculating the degree by a computer software

2

Description
columella show
Timepoint
pre and postoperation rhinoplasty surgery
Method of measurement
mm by calliper

Secondary outcomes

1

Description
patient satisfaction
Timepoint
after surgery
Method of measurement
chek list

Intervention groups

1

Description
cuadal extension graft method
Category
Treatment - Surgery

2

Description
columellar strut with plumping graft method
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Shahid Sadoughi Hospital
Full name of responsible person
Dr. Batoolsadat Sadjadinejad
Street address
Yazd Shahid Sadoughi Hospital, riyaziyazdi square
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Associate dean for research and innovation, Shahid Sadoughi University of Medical Sciences and Healt
Full name of responsible person
Dr. Fatemeh Ezoddini
Street address
The Central Organization of Medical Sciences and Health Services Martyr Sadoughi, Martyr Dr Bahonar Square3
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Associate dean for research and innovation, Shahid Sadoughi University of Medical Sciences and Healt
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Batool Sadat Sadjadinejad
Position
Otolaryngology Head and Neck Surgery resident
Other areas of specialty/work
Street address
Shahid Sadoughi University of Medical Sciences and Health Services, Department of Otolaryngology Head and Neck Surgery
City
Yazd
Postal code
8915887857
Phone
+98 35 1724 0171
Fax
Email
bs_sajadi@yahoo.com; atighechi@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr. Saeid Atighechi
Position
Associate Professor
Other areas of specialty/work
Street address
Yazd. Martyr Sadoughi Hospital.Safaiye
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
bs_sajadi@yahoo.com; atighechi@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr. Batoolsadat Sadjadinejad
Position
Otolaryngology Head and Neck Surgery resident
Other areas of specialty/work
Street address
Martyr Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4001
Fax
Email
bs_sajadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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