Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
Primary Purpose
Nasal Obstruction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Submucous Resection with non powered instrument
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Obstruction
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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Submucous Resection (SMR)
Arm Description
Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)
Turbinoplasty using non-powered instruments
Outcomes
Primary Outcome Measures
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
Measure of pain on the Visual Analog Scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02695602
Brief Title
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
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit enough patients
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 9, 2017 (Actual)
Study Completion Date
May 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Arm Type
Experimental
Arm Description
Turbinoplasty using microdebrider turbinate blade (2.9mm inferior turbinate blade, Medtronic, 5000 Hz)
Arm Title
Submucous Resection (SMR)
Arm Type
Experimental
Arm Description
Turbinoplasty using non-powered instruments
Intervention Type
Procedure
Intervention Name(s)
Microdebrider-Assisted Inferior Turbinoplasty (MAIT)
Other Intervention Name(s)
Medtronic
Intervention Type
Procedure
Intervention Name(s)
Submucous Resection with non powered instrument
Other Intervention Name(s)
Jansen-Middleton or straight through cut
Primary Outcome Measure Information:
Title
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
Time Frame
3 years post-operative
Title
Measure of pain on the Visual Analog Scale
Time Frame
3 years post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Lieberman
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
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