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

Stopped early · Not applicable

Conditions studied: Nasal Obstruction

In brief

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.

Key facts

Study ID

NCT02695602

Run by

NYU Langone Health

People needed

2

Starts

2016-02-01

Expected to finish

2017-05-09

Last updated by the study team

2017-05-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.