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NCT Number: NCT01054521

A Randomized Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction

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.

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Key information

Conditions

Patients With Chronic Rhinitis Who Failed Medical Treatment Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj Hospital

Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Temperature-controlled RF

Procedure

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.

Other names: Temperature-controlled RF device is Gyrus ENT.

Bipolar RF

Device

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.

Other names: Bipolar RF device is Select Sutter.

Primary outcomes

  1. Visual Analog scale scores of nasal obstructive symptom.

    Time frame: Up to 1 year follow-up

Secondary outcomes

  1. VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip

    Time frame: Up to 1 year follow-up

    Shor-term at 4th week and long-term at 1 year follow-up

  2. Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa

    Time frame: Up to 1 year follow-up

    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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis

Acronym: CompareRFIT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 22, 2010
Registry last updated
Jun 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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