Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty

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

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.

Study Overview

• Status: Completed
• Conditions: Cosmetic Outcome
• Intervention / Treatment: Procedure: stair step incisions; Procedure: inverted V incision

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of, 94305
    • Tehran University Of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients who candidate for open rhinoplasty

Exclusion Criteria:

• Revision cases
• History of scar
• Systemic diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A; stair step incisions	Procedure: stair step incisions; It is a type of incision
Active Comparator: Group B; inverted V incision	Procedure: inverted V incision; It is a type of incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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
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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Babak Saaedi, Tehran University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 11, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): January 20, 2014
• Last Update Submitted That Met QC Criteria: January 17, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 92-01-48-20912