Plain English Summary
Background and study aims
Lateral nasal wall collapse (collapse of the side of the nose) can cause nasal congestion. The side of the nose (nasal sidewall) collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is a technique used by many surgeons to treat it. It involves anchoring the nasal sidewall to the bony rim below the eye. A recently described technique involves treating the soft tissue of the side of the nose with radiofrequency heat to create a scar that makes the tissue firmer. We want to compare the two treatments to each other. We hope to determine how well the new technique performs in managing lateral nasal wall collapse when compared to one of the standard surgical treatments and also non- surgical treatments. This knowledge could change surgical management as radiofrequency thermotherapy is less invasive, could be performed with only local anesthesia, and does not involve implants - in contrast to the more established bone anchored suture suspension.
Who can participate?
Adults (aged over 18) with nasal obstruction (blockage).
What does the study involve?
Participants are randomly allocated into one of three groups. Those in group 1 are treated using radiofrequency thermotherapy. Those in group 2 are treated using the conventional bone anchored suture suspension technique. Those in group 3 are given non-operative treatments. All patients are assessed for lateral wall insufficiency, nasal obstruction and pain caused by the nasal obstruction before and after treatment.
What are the possible benefits and risks of participating?
Radiofrequency thermotherapy of the lateral nasal wall is a new technique, but radiofrequency treatment itself is well established in the field of otolaryngology (ear, nose and throat specialists) to treat conditions such sleep apnea and other causes of nasal obstruction. Known risks include excess thermal (heat) damage and pain.
Where is the study run from?
Stanford University (USA)
When is the study starting and how long is it expected to run for?
February 2010 to February 2012
Who is funding the study?
1. Stanford University (USA)
2. American Academy of Facial Plastic & Reconstructive Surgery (USA)
Who is the main contact?
Dr Sam Most
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
IRB-18115
Study information
Scientific title
Treatment of lateral nasal wall collapse - a comparison of Bone Anchored SuTure suspension versus Radiofrequency Thermotherapy.
Acronym
BAST vs RF
Study hypothesis
Our hypothesis is that RF will work as well as bone-anchored sutures in treatment of lateral wall insufficiency (LWI).
Ethics approval
Stanford Human Subjects, 2/3/2010, ref: IRB-18115
Study design
This is a single-center, randomized, interventional trial comparing two techniques for treatment of lateral wall insufficiency.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Lateral nasal wall collapse is a source of nasal congestion which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose.
Intervention
Bone anchored suture suspension is used by many surgeons to treat lateral wall insufficiency, and involves anchoring the nasal sidewall to the bony rim below the eye. A recently described technique involves treating the sidewall soft tissue with radiofrequency heat to cause scar contraction of the tissue to minimize laxity. We will compare the two treatments to each other, and to non-operative treatment of otherwise surgically-eligible candidates.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. Clinician-derived measure of lateral wall insufficiency (LWI score).
2. NOSE (nasal obstruction symptoms evaluation)
Measured at preoperative and postoperative visits.
Secondary outcome measures
1. Visual analog scale for nasal obstruction (VAS)
Measured at preoperative and postoperative visits.
Overall trial start date
01/02/2010
Overall trial end date
28/02/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy adults with nasal obstruction
2. Over age 18
3. Either gender
4. Any ethnic background
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Children
2. Pregnant women
Recruitment start date
01/02/2010
Recruitment end date
28/02/2012
Locations
Countries of recruitment
United States of America
Trial participating centre
Stanford University
United States of America
Funders
Funder type
University/education
Funder name
Stanford University
Alternative name(s)
SU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United States of America
Funder name
Educational and Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery
Alternative name(s)
AAFPRS Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Paper accepted by JAMA Facial Plastic Surgery
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25633257