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The Role of Spreader Flaps in Preventing of Nasal Obstruction

Primary Purpose

Nasal Obstruction

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
spreader flap
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who underwent rhinoplasty

Exclusion Criteria:

  • revision rhinoplasty
  • congenital malformations
  • severe allergic rhinitis
  • nasal polyposis
  • sinusitis
  • deviated nose

Sites / Locations

  • Imam Khomeini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

spreader flap

Control group

Arm Description

Usage of spreader flap of upper lateral cartilage

performing of rhinoplasty without spreader flap

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2013
Last Updated
July 23, 2013
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01907243
Brief Title
The Role of Spreader Flaps in Preventing of Nasal Obstruction
Official Title
The Role of Spreader Flaps in Preventing of Nasal Obstruction in Primary Rhinoplasty: A Randomized-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
spreader flap
Arm Type
Active Comparator
Arm Description
Usage of spreader flap of upper lateral cartilage
Arm Title
Control group
Arm Type
No Intervention
Arm Description
performing of rhinoplasty without spreader flap
Intervention Type
Procedure
Intervention Name(s)
spreader flap
Intervention Description
producing of upper lateral cartilage flap as a spreader flap
Primary Outcome Measure Information:
Title
acoustic rhinometry ( minimum cross section area)
Description
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
Time Frame
before surgery
Secondary Outcome Measure Information:
Title
acoustic rhinometry ( minimum cross section area)
Description
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
Time Frame
one year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who underwent rhinoplasty Exclusion Criteria: revision rhinoplasty congenital malformations severe allergic rhinitis nasal polyposis sinusitis deviated nose
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babak Saaedi
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imam Khomeini Hospital
City
Tehran
ZIP/Postal Code
94305
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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The Role of Spreader Flaps in Preventing of Nasal Obstruction

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