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Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
RECRUITINGN/ASponsored by Northwell Health
Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2021-04-30
Est. completion2024-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05287841
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 arm), both in terms of subjective and objective assessments.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Patients should satisfy all the following criteria to be considered eligible for randomization: 1. Be age 18 or above 2. Able to provide written informed consent 3. Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices. <!-- --> 1. Septal deviation must be present on direct or endoscopic examination 2. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination 3. Collapse of external nasal valve and/or lateral motion instability must be documented <!-- --> 1. 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 Criteria: 1. Septal perforation 2. History of previous functional rhinoplasty or sinus or septal surgery 3. Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty 4. Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management 5. Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
Conditions6
Allergic RhinitisHeart DiseaseNasal ObstructionNasal PolypsNasal Valve CollapseSeptal Defect
Locations3 sites
Missouri
1 sitePoplar Bluff Regional Medical Center
Poplar Bluff, Missouri, 63901
New York
2 sitesLenox Hill Hospital/Staten Island University Hospital
New York, New York, 10075
Staten Island University Hospital
Staten Island, New York, 10305
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Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2021-04-30
Est. completion2024-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05287841