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

Nasal Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02695602
• Other study ID #: 15-01264
• Status: Terminated
• Phase: N/A
• First received: February 4, 2016
• Last updated: May 9, 2017
• Start date: February 2016
• Est. completion date: May 9, 2017

Study information

• Verified date: May 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Procedure:
• Microdebrider-Assisted Inferior Turbinoplasty (MAIT)

• Submucous Resection with non powered instrument

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients		3 years post-operative
Primary	Measure of pain on the Visual Analog Scale		3 years post-operative