Clinical Trials Directory

Trials / Completed

CompletedNCT01907243

The Role of Spreader Flaps in Preventing of Nasal Obstruction

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Tehran University of Medical Sciences · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREspreader flapproducing of upper lateral cartilage flap as a spreader flap

Timeline

Start date
2011-05-01
Primary completion
2012-11-01
Completion
2013-04-01
First posted
2013-07-24
Last updated
2013-07-24

Locations

1 site across 1 country: Iran

Source: ClinicalTrials.gov record NCT01907243. Inclusion in this directory is not an endorsement.