Nasal ObstructionPhase 3NCT01907243
The Role of Spreader Flaps in Preventing of Nasal Obstruction
A Phase 3 study testing spreader flap in people with Nasal Obstruction, run by Tehran University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- spreader flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteIran
- Study dates
- May 2011to Apr 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who underwent rhinoplasty
Who cannot join
- revision rhinoplasty
- congenital malformations
- severe allergic rhinitis
- nasal polyposis
- sinusitis
- deviated nose
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Spreader Flaps in Preventing of Nasal Obstruction in Primary Rhinoplasty: A Randomized-controlled Trial.
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.
Read the 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
- Nasal Obstruction
- Being tested
- spreader flap
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spreader flapProcedure or surgery
producing of upper lateral cartilage flap as a spreader flap
| Study group | Role | What they receive |
|---|---|---|
| spreader flap | Active comparator | Usage of spreader flap of upper lateral cartilage Receives: Procedure: spreader flap |
| Control group | No intervention | performing of rhinoplasty without spreader flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: before surgery
Secondary outcomes (1)
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
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babak Saedi, Tehran University of Medical Sciences
- Investigators
- Babak Saaedi, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907243
- Sponsor's protocol ID
- 91--02-48-6933
- Status last verified
- Jul 2013
- First submitted
- 11 Jul 2013
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Spreader Flaps in Preventing of Nasal Obstruction in Primary Rhinoplasty: A Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT01907243
- Acronym / sponsor ID
- 91--02-48-6933
- Conditions
- Nasal Obstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spreader flap | Active comparator | Procedure: spreader flapUsage of spreader flap of upper lateral cartilage |
| Control group | No intervention | –performing of rhinoplasty without spreader flap |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who underwent rhinoplasty
Key exclusion criteria (6 listed)
- revision rhinoplasty
- congenital malformations
- severe allergic rhinitis
- nasal polyposis
- sinusitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spreader flapproducing of upper lateral cartilage flap as a spreader flap | Procedure or surgery | spreader flap |
Primary outcome
acoustic rhinometry ( minimum cross section area)
Time frame: before surgery
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
1 secondary outcome
acoustic rhinometry ( minimum cross section area)
Time frame: one year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
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A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Saaedi principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing spreader flap in people with Nasal Obstruction, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acoustic rhinometry ( minimum cross section area) (time frame: before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2013.