Actively Recruiting
Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
Led by Northwell Health · Updated on 2024-09-20
96
Participants Needed
3
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of adding batten grafts to the standard septoplasty and turbinate reduction surgeries for nasal obstruction caused by septal deviation and related issues. The study focuses on improving nasal airflow and reducing future surgeries by addressing not only septal deviation and inferior turbinate hypertrophy but also nasal valve collapse, which can contribute to breathing difficulties. Participants will be randomly assigned to one of two groups. In the intervention group, a piece of the patient's own nasal septal cartilage will be reshaped and re-implanted as a batten graft during septoplasty and turbinate reduction. The control group will receive the standard septoplasty and turbinate reduction without the batten graft. The study evaluates these approaches over a 12-month period, measuring nasal symptoms and airflow. During the trial, participants will undergo evaluations including symptom questionnaires and airflow measurements at 12 months after surgery. Researchers will monitor nasal obstruction symptoms, nasal valve function, peak inspiratory flow, any complications or side effects, cost-effectiveness, and the need for additional surgeries. The total participation time includes follow-up assessments over one year to assess long-term outcomes.
CONDITIONS
Brief Title
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be age 18 or above
- Able to provide written informed consent
- Have an indication for batten graft, septoplasty, and turbinate reduction according to surgical practices
- Septal deviation present on direct or endoscopic examination
- Inferior turbinate hypertrophy present on direct or endoscopic examination
- Documented collapse of external nasal valve and/or lateral motion instability
- Endoscopic examination confirms septal deviation, turbinate hypertrophy, and nasal valve collapse as primary causes of breathing obstruction
You will not qualify if you...
- Septal perforation
- History of previous functional rhinoplasty or sinus or septal surgery
- Selected for concurrent aesthetic/cosmetic rhinoplasty
- Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- Concurrent sinus surgery, polyp removal, or concha bullosa resection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery and immediate recovery period
Participants undergo septoplasty and inferior turbinate reduction, with or without the addition of a batten graft to support the nasal structure.
1 surgery visit (in-person)
Duration - Up to 12 months
Participants are monitored to assess nasal outcomes, complications, and recovery after surgery.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 3 locations
1
Poplar Bluff Regional Medical Center
Poplar Bluff, Missouri, United States, 63901
Not Yet Recruiting
2
Lenox Hill Hospital/Staten Island University Hospital
New York, New York, United States, 10075
Actively Recruiting
3
Staten Island University Hospital
Staten Island, New York, United States, 10305
Actively Recruiting
Research Team
R
Research Department
D
David Hiltzik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here