The Role of Spreader Flaps in Preventing of Nasal Obstruction

NCT01907243 | Completed Phase 3

• 1 other identifier: 91--02-48-6933
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• acoustic rhinometry ( minimum cross section area)

  one year after surgery

Study Arms (2)

spreader flap

ACTIVE COMPARATOR

Usage of spreader flap of upper lateral cartilage

Procedure: spreader flap

Control group

NO INTERVENTION

performing of rhinoplasty without spreader flap

Interventions

spreader flap PROCEDURE

producing of upper lateral cartilage flap as a spreader flap

spreader flap

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent rhinoplasty

You may not qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital

Tehran, Tehran Province, 94305, Iran

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Officials

• Babak Saaedi

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 24, 2013
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: April 1, 2013
• Last Updated: July 24, 2013

Record last verified: 2013-07

Locations

IR (1)