Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)



Status:Terminated
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 70
Updated:5/11/2017
Start Date:February 2016
End Date:May 9, 2017

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Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)

This is a prospective, patient blinded, randomized, clinical trial enrolling patients with
symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose
of this study is to compare two different surgical methods, both of which are already in
common use, for the treatment of nasal obstruction in patients with inferior turbinate
hypertrophy.


Inclusion Criteria:

- Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy,
with or without septal deviation will be eligible for the study.

- Failed medical treatment

- Have failed medical treatment for at least 1 month, and will be offered surgery

- Patients having Septoplasty at the same time as their turbinate reduction surgery.

Exclusion Criteria:

- Patients who have had previous turbinate reduction surgery will be excluded.

- Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal
tumors, or any other exam finding that would explain their symptoms of nasal
obstruction other than enlarged inferior turbinates with or without septal deviation
will be excluded.

- Patients who are diagnosed with purely bony inferior turbinate hypertrophy as
discussed below.

- Patients on hormone or anticoagulation therapy and those who have a history of head
and neck radiation therapy will be excluded.

- All study candidates will be assessed for external nasal valve collapse via the
modified Cottle maneuver, and will be excluded if they exhibit significant external
or internal nasal valve collapse as their primary cause of their nasal obstruction.

- All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before
and after decongestion at their preoperative visit. Patients that fail to report a
score less than 5 after decongestion are likely to have bony rather than soft tissue
hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option,
and they would derive a greater amount of benefit from SMR. Therefore these patients
will be excluded from the study, and offered only SMR.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Seth Lieberman, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
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from
New York, NY
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