Status:
RECRUITING
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Lead Sponsor:
Northwell Health
Conditions:
Nasal Obstruction
Septal Defect
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control ...
Detailed Description
One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to sep...
Eligibility Criteria
Inclusion
- Patients should satisfy all the following criteria to be considered eligible for randomization:
- Be age 18 or above
- Able to provide written informed consent
- Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.
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- Septal deviation must be present on direct or endoscopic examination
- Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
- Collapse of external nasal valve and/or lateral motion instability must be documented
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- The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.
- In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.
Exclusion
- Septal perforation
- History of previous functional rhinoplasty or sinus or septal surgery
- Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
- Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2025
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05287841
Start Date
April 30 2021
End Date
June 15 2025
Last Update
September 20 2024
Active Locations (3)
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1
Poplar Bluff Regional Medical Center
Poplar Bluff, Missouri, United States, 63901
2
Lenox Hill Hospital/Staten Island University Hospital
New York, New York, United States, 10075
3
Staten Island University Hospital
Staten Island, New York, United States, 10305