A comparison of bone-anchored sutures and radiofrequency energy for treatment of lateral wall collapse causing nasal obstruction.

ISRCTN	ISRCTN14219489
DOI	https://doi.org/10.1186/ISRCTN14219489
Secondary identifying numbers	IRB-18115

Submission date: 17/12/2014
Registration date: 12/01/2015
Last edited: 02/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr. Sam Most
Scientific

801 Welch Road
Stanford
94305
United States of America

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Treatment of lateral nasal wall collapse - a comparison of Bone Anchored SuTure suspension versus Radiofrequency Thermotherapy.
Study acronym	BAST vs RF
Study objectives	Our hypothesis is that RF will work as well as bone-anchored sutures in treatment of lateral wall insufficiency (LWI).
Ethics approval(s)	Stanford Human Subjects, 2/3/2010, ref: IRB-18115
Health condition(s) or problem(s) studied	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
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 study start date	01/02/2010
Completion date	28/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	30
Key inclusion criteria	1. Healthy adults with nasal obstruction 2. Over age 18 3. Either gender 4. Any ethnic background
Key exclusion criteria	1. Children 2. Pregnant women
Date of first enrolment	01/02/2010
Date of final enrolment	28/02/2012

Locations

Countries of recruitment

United States of America

Study participating centre

Stanford University

United States of America

Sponsor information

Stanford University Department of Otolaryngology
University/education

801 Welch Road
Stanford
94305
United States of America

"ROR"	https://ror.org/00f54p054

Funders

Funder type

University/education

Stanford University
Government organisation / Universities (academic only)

Alternative name(s): Stanford, Leland Stanford Junior University, SU
Location: United States of America

Educational and Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery
Government organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): AAFPRS Foundation, Educational & Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery, Educational and Research Foundation for the American Academy of Facial, AAFPRS Foundation; Educational & Research Foundation for the American Academy of Facial Plastic and Reconstructive Surgery, AMERICAN ACADEMY OF FACIAL PLASTIC AND RECONSTRUCTIVE SURGERY, INC., AAFPRS
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Paper accepted by JAMA Facial Plastic Surgery
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2015		Yes	No