Randomized Trial Comparing Partial Resection of Inferior Turbinate(PRIT) and Radiofrequency Ablation(RFA) for Inferior Turbinate Reduction

February 24, 2016 updated by: Weill Medical College of Cornell University

A Randomized Trial Comparing Two Surgical Techniques for Inferior Turbinate Reduction

Turbinates are large structures in the nasal airway that help the nose to clean and humidify the air we breathe. Inferior turbinates can swell up and block the breathing passage, making it hard to breath. To address this, turbinate size must be reduced.

This study looks at two common procedures for turbinate reduction:

  1. Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior (lower) turbinate that releases thermal energy, which significantly reduces its size. This can be done under local anesthesia at the doctor's office.
  2. Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a piece off the turbinate, which also reduces its size.

While both procedures improve nasal obstruction, no study has directly compared which is more effective.

Eighty patients being treated for septal deformity and turbinate hypertrophy will be randomly chosen for either PRIT or RFA treatment. They will fill out a simple, five question survey that measures how they view their nasal blockage 4 times in one year. We believe that since PRIT permanently removes a part of the turbinate, PRIT patients will report more improvement than RFA patients one year later. We believe that complications (measured by the doctor) will be the same for both treatments.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Subjective nasal obstruction is usually caused by intranasal anatomic obstruction. A critical area is the anterior nasal valve, and nasal septal deformity and inferior turbinate hypertrophy often combine to produce symptomatic obstruction at the anterior valve.

Surgical treatments to reduce turbinate size and also to correct nasal septal deformity have been shown to be effective at improving nasal obstruction. While many studies have demonstrated the improvements after surgery, most prior studies assessed outcome using non-validated questionnaires, or primitive measures such as a single-item rating scale.

There is now a validated, patient-based, outcome instrument to assess nasal obstruction, which is valid, reliable, and sensitive: the Nasal Obstruction Symptom Evaluation (NOSE) scale (Stewart, Witsell, et al). This brief and easy to complete instrument is a valid measure of the patient's perception of nasal obstruction. A multi-center prospective study using the NOSE scale showed that septoplasty alone resulted in significant improvement in nasal obstruction, and septoplasty with PRIT had an even larger improvement in nasal obstruction, although the difference did not reach statistical significance because of sample size (Stewart, Smith, et al). Nevertheless, turbinate reduction appeared to have some additive effect on symptomatic improvement, which is a clinical findings that has been noted by surgeons for many years.

The techniques of inferior turbinectomy have evolved over time. Initially, partial or even total resection of the inferior turbinate was performed. However, total inferior turbinate resection was found to have a high rate of several long-term complications, including excessive dryness (rhinitis sicca), atrophic rhinitis, crusting, bleeding, etc. (Moore GF, Moore EJ), and this technique is generally not performed today. By extension, many surgeons have been concerned about the potential sequelae of partial inferior turbinectomy, even though large prospective series have demonstrated excellent outcomes and minimal complications from the PRIT technique (Fanous, Ophir, Grymer, Stewart/Smith).

Several alternative techniques for turbinate volume reduction - that do not involve full-thickness resection of a portion of the turbinate - have been reported, and all seem to be effective in single-modality series (Nease, Bhattacharyya, Utley, Li). In fact, anecdotally many surgeons claim that RFA is as effective as PRIT. In addition, radiofrequency techniques can be performed under local anesthesia in the office setting, which increases the ease of use. While RFA is appealing because it can be performed under local anesthesia, the improved ease of use must be weighed against the potential for lower effectiveness, since tissue is not removed. There are no data from direct comparative studies, probably partly because there has not been a validated outcome tool available.

Therefore, sufficient clinical equipoise exists to randomize patients to receive one of these two widely-accepted techniques.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Study subjects will be male or female, 18 years or older, with nasal septal deformity and bilateral inferior turbinate hypertrophy

Exclusion Criteria:

  • Subjects with contraindication to general anesthesia or nasal surgery
  • Additional simultaneous nasal surgery, such as sinus surgery or rhinoplasty
  • Nasal polyposis and prior inferior turbinectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RFA
Radiofrequency Ablation (RFA) involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.
Procedure: Radiofrequency Ablation (RFA)
RFA involves inserting a special needle into the inferior (lower) turbinate that releases high frequency energy, which produces heat. The energy and heat cause tissue denaturation (protein damage) and vaporization. The vaporization reduces tissue volume, and denaturation causes healing with scar tissue formation and contraction of surrounding tissue. This procedure can be done under local anesthesia at the doctor's office.
Active Comparator: PRIT
Partial Resection of Inferior Turbinate (PRIT) involves surgically removing a small piece off the turbinate, which also reduces its size.
Procedure: Partial Resection of Inferior Turbinates (PRIT)
PRIT involves surgically removing a small piece off the turbinate, which also reduces its size.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint for the 80 subjects enrolled will be the NOSE Score at 12 months.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The prevalence of complications.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Michael G Stewart, MD, MPH, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

July 27, 2006

First Submitted That Met QC Criteria

July 27, 2006

First Posted (Estimate)

July 31, 2006

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603008446

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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