The Role of Spreader Flaps in Preventing of Nasal Obstruction

Nasal Obstruction Clinical Trial

Official title:

The Role of Spreader Flaps in Preventing of Nasal Obstruction in Primary Rhinoplasty: A Randomized-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907243
• Other study ID #: 91--02-48-6933
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2013
• Last updated: July 23, 2013
• Start date: May 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Nasal obstruction is a preventable complication of rhinoplasty, for which the spreader graft is the gold standard. More recently, the spreader flap technique has been espoused as an alternative to spreader grafting. Herein we evaluated the efficacy of this technique in a randomized trial setting.

Description:

Rhinoplasty is a common facial plastic surgery procedure, one complication of which is nasal vault narrowing and consequent nasal obstruction. Recently, researchers have paid much attention to nasal valve area and especially to the role of upper lateral cartilage (ULC) in preserving of nasal patency, since a possible consequence of destructive techniques was permanent functional problems for patients. In addition to functional problems, it can cause some aesthetic problems such as the inverted-V deformity . Accordingly, reconstruction of the midvault after dorsal reduction has been advocated and widely adopted.

The gold standard for midvault reconstruction after dorsal reduction has been the spreader graft, first advocated by Sheen . Subsequently, its usage has been widened to include repair of the valve in the unoperated nose, and its efficacy well-documented. However, it can be a time-consuming procedure that requires the harvest of septal cartilage. Therefore, some authors proposed the spreader flap as an alternative technique. While the results of the above mentioned articles proposed the efficacy of spreader flaps, none of them was a randomized trial and subjective methods were used for measurement of nasal breathing after rhinoplasty.

Nasal obstruction can be evaluated in different methods, both quantitative and subjective, the validity of each debated. For example, while the numeric form of Visual Analogue Scale (VAS) is commonly used, it is ultimately related to patients' subjective perception. Alternatively, objective evaluation of nasal patency is also of common interest to many researchers, and various methods for objective measurement exist. Among these different methods, acoustic rhinomanometry is an effective tool. However, some researchers debate the reliability of these results. Herein we examine the efficacy of the spreader flap in preventing nasal obstruction after dorsal reduction using a randomized trial with both objective and subjective measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients who underwent rhinoplasty

Exclusion Criteria:

• revision rhinoplasty

• congenital malformations

• severe allergic rhinitis

• nasal polyposis

• sinusitis

• deviated nose

Study Design

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

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Procedure:
• spreader flap
producing of upper lateral cartilage flap as a spreader flap

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini Hospital	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	acoustic rhinometry ( minimum cross section area)	acoustic rhinomanometery GM (ARI model, U.K) with an ultrasound system 0/8. (US-100, Japan) All tests were done while the patients were sitting while holding the device before his nose, completely sealing the nose, without excessive pressure cause changing of the nasal shape.; Reducing the possible mucosal effect on acoustic rhinomanometry results, all tests were performed 10 minutes after the decongestant (Oxymetasoline spray) usage.; Finally, a graph was drawn with two notches wherein the first notch related the valve area and the second one related to anterior part of lower turbinate. Each examination consisted of three consecutives tests from which the minimum cross section area was calculated	before surgery	Yes
Secondary	acoustic rhinometry ( minimum cross section area)	coustic rhinomanometery GM (ARI model, U.K) with an ultrasound system 0/8. (US-100, Japan) All tests were done while the patients were sitting while holding the device before his nose, completely sealing the nose, without excessive pressure cause changing of the nasal shape.; Reducing the possible mucosal effect on acoustic rhinomanometry results, all tests were performed 10 minutes after the decongestant (Oxymetasoline spray) usage.; Finally, a graph was drawn with two notches wherein the first notch related the valve area and the second one related to anterior part of lower turbinate. Each examination consisted of three consecutives tests from which the minimum cross section area was calculated	one year after surgery	Yes