Clinical trial NCT02695602: Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
Official title: Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
timeFrame: 3 years post-operative
measure: Measure of pain on the Visual Analog Scale
timeFrame: 3 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Seth Lieberman
role: PRINCIPAL_INVESTIGATOR
References: