Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Babak Saedi, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01907256
First received: July 11, 2013
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Cosmetic Outcome
Procedure: inverted V incision
Procedure: stair step incisions
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Hollunder cosmetic score [ Time Frame: one week after surgery, ] [ Designated as safety issue: Yes ]
    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

  • Hollunder cosmetic score [ Time Frame: one month after surgery ] [ Designated as safety issue: Yes ]
    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

  • Hollunder cosmetic score [ Time Frame: one year after surgery ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Visual analogue score [ Time Frame: one week after surgery, ] [ Designated as safety issue: Yes ]
    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

  • Visual analogue score [ Time Frame: one month after surgery ] [ Designated as safety issue: Yes ]
    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

  • Visual analogue score [ Time Frame: one year after surgery ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 56
Study Start Date: December 2012
Study Completion Date: November 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who candidate for open rhinoplasty

Exclusion Criteria:

  • Revision cases
  • History of scar
  • Systemic diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907256

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 94305
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Babak Saaedi Tehran University of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Babak Saedi, Associate professor, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01907256     History of Changes
Other Study ID Numbers: 92-01-48-20912
Study First Received: July 11, 2013
Last Updated: January 17, 2014
Health Authority: Iran: Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014