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Completed

NCT Number: NCT01907256

Comparing the Aesthetic Results of Two Common Incisions in External Rhinoplasty

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tehran University of Medical Sciences

Tehran, Tehran Province, 94305, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients who candidate for open rhinoplasty

Exclusion criteria

  • Revision cases
  • History of scar
  • Systemic diseases

Treatment and study plan

inverted V incision

Procedure

It is a type of incision

stair step incisions

Procedure

It is a type of incision

Primary outcomes

  1. Hollunder cosmetic score

    Time frame: one week after surgery,

    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

  2. Hollunder cosmetic score

    Time frame: one month after surgery

    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

  3. Hollunder cosmetic score

    Time frame: one year after surgery

    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 outcomes

  1. Visual analogue score

    Time frame: one week after surgery,

    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

  2. Visual analogue score

    Time frame: one month after surgery

    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

  3. Visual analogue score

    Time frame: one year after surgery

    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

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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