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

This study has been terminated.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00358267
First received: July 27, 2006
Last updated: April 30, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Nasal Obstruction
Septal Deformity
Turbinate Hypertrophy
Procedure: Partial Resection of Inferior Turbinates (PRIT)
Procedure: Radiofrequency Ablation (RFA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Two Surgical Techniques for Inferior Turbinate Reduction

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • The primary endpoint for the 80 subjects enrolled will be the NOSE Score at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The prevalence of complications. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00358267

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michael G Stewart, MD, MPH Weill Medical College of Cornell University
  More Information

Publications:

Responsible Party: Michael G. Stewart MD MPH, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00358267     History of Changes
Other Study ID Numbers: 0603008446
Study First Received: July 27, 2006
Last Updated: April 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Inferior Turbinate Reduction
Partial Resection of Inferior Turbinates (PRIT)
Radiofrequency Ablation (RFA)
NOSE scale
Nasal Obstruction

Additional relevant MeSH terms:
Hypertrophy
Nasal Obstruction
Pathological Conditions, Anatomical
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014