Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty

Cosmetic Outcome Clinical Trial

Official title:

Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907256
• Other study ID #: 92-01-48-20912
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2013
• Last updated: January 17, 2014
• Start date: December 2012
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Description:

Approaches to rhinoplasty can be separated into two broad categories: external and endonasal, which each of them their own proponent. However, the external approach provide better exposure, critics against this technique is often due to cosmetic deformity regarding the incision. Hence, over the recent years surgeons have modified the trans-columellar incision into two big categories: gull wing and stair steps. While each of them has its own proponents, there is no randomized trial, comparing their cosmetic results.

There was not any randomize trial to show what is the best type of incision in open rhinoplasty. So, we use both self-rating by patients ,independent physician observers Visual Analogue Scale (VAS) and also a validated scar analysis to compare inverted V and stair step incisions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All patients who candidate for open rhinoplasty

Exclusion Criteria:

• Revision cases

• History of scar

• Systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cosmetic Outcome

Intervention

Procedure:
• inverted V incision
It is a type of incision
• stair step incisions
It is a type of incision

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hollunder cosmetic score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery	one week after surgery,	Yes
Primary	Hollunder cosmetic score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery	one month after surgery	Yes
Primary	Hollunder cosmetic score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale in one week after surgery, one month after surgery , one year after surgery	one year after surgery	Yes
Secondary	Visual analogue score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery	one week after surgery,	Yes
Secondary	Visual analogue score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery	one month after surgery	Yes
Secondary	Visual analogue score	The patients will come for office visit and their columella scars will evaluate according to above mentioned scale inone week after surgery, one month after surgery , one year after surgery	one year after surgery	Yes