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



Status:Withdrawn
Conditions:Other Indications, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2006
End Date:March 2009

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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.

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.

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
We found this trial at
1
site
445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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New York, NY
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