Back to resultsA Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction (CompareRFIT)
Primary Purpose
Patients With Chronic Rhinitis Who Failed Medical Treatment
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Temperature-controlled RF
Bipolar RF
Sponsored by
About this trial
This is an interventional treatment trial for Patients With Chronic Rhinitis Who Failed Medical Treatment focused on measuring radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.
Eligibility Criteria
Inclusion Criteria:
- Adults with snoring and chronic nasal obstruction.
- Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
- Consent to the protocol.
Exclusion Criteria:
- Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
- Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
- Not complete the protocol
Sites / Locations
- Siriraj Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Temperature-controlled RF (TCRF)
Bipolar RF (BRF)
Arm Description
The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.
The bipolar RF (BRF) probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Outcomes
Primary Outcome Measures
Visual Analog scale scores of nasal obstructive symptom.
Secondary Outcome Measures
VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip
Shor-term at 4th week and long-term at 1 year follow-up
Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa
Crusting was assessed at 1st week and 4th week, MTT at 4th week, and MCA, VOL, and NAR were assessed before and after treatment at 4th week and one year follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01054521
Brief Title
A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction
Acronym
CompareRFIT
Official Title
A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Chronic Rhinitis Who Failed Medical Treatment
Keywords
radiofrequency turbinate reduction, nasal obstruction, Temperature-controlled radiofrequency, Bipolar radiofrequency, chronic rhinitis.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Temperature-controlled RF (TCRF)
Arm Type
Experimental
Arm Description
The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.
Arm Title
Bipolar RF (BRF)
Arm Type
Active Comparator
Arm Description
The bipolar RF (BRF) probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Intervention Type
Procedure
Intervention Name(s)
Temperature-controlled RF
Other Intervention Name(s)
Temperature-controlled RF device is Gyrus ENT.
Intervention Description
The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.
For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Intervention Type
Device
Intervention Name(s)
Bipolar RF
Other Intervention Name(s)
Bipolar RF device is Select Sutter.
Intervention Description
The bipolar RF probe will be inserted at the same area with TCRF. The energy used will be 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Primary Outcome Measure Information:
Title
Visual Analog scale scores of nasal obstructive symptom.
Time Frame
Up to 1 year follow-up
Secondary Outcome Measure Information:
Title
VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip
Description
Shor-term at 4th week and long-term at 1 year follow-up
Time Frame
Up to 1 year follow-up
Title
Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa
Description
Crusting was assessed at 1st week and 4th week, MTT at 4th week, and MCA, VOL, and NAR were assessed before and after treatment at 4th week and one year follow-up
Time Frame
Up to 1 year follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with snoring and chronic nasal obstruction.
Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
Consent to the protocol.
Exclusion Criteria:
Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
Not complete the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wish Banhiran, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
25432641
Citation
Banhiran W, Assanasen P, Tantilipikorn P, Nujchanart N, Voraprayoon S, Bunnag C. A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction. Eur Arch Otorhinolaryngol. 2015 Oct;272(10):2877-84. doi: 10.1007/s00405-014-3410-y. Epub 2014 Nov 29.
Results Reference
derived
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A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction
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