Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Recruiting now · Not applicable
Conditions studied: Nasal Obstruction, Septal Defect, Allergic Rhinitis, Nasal Polyps, Nasal Valve Collapse
In brief
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 arm), both in terms of subjective and objective assessments.
Key facts
- Study ID
- NCT05287841
- Run by
- Northwell Health
- People needed
- 96
- Starts
- 2021-04-30
- Expected to finish
- 2025-06-15
- Last updated by the study team
- 2024-09-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Lenox Hill Hospital/Staten Island University Hospital — New York, New York, United States (enrolling)
- Staten Island University Hospital — Staten Island, New York, United States (enrolling)
- Poplar Bluff Regional Medical Center — Poplar Bluff, Missouri, United States
Full record on ClinicalTrials.gov
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