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Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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.
What is being tested
- Batten batten graft (procedure)
- Septoplasty (procedure)
- Inferior Turbinate Reduction (procedure)
Sponsor: Northwell Health · Participants: 96 · Started: Apr 30, 2021
Contact the study team
- Research Department · Phone: 718-226-6256
- David Hiltzik, MD · Phone: 212-434-4500
Official record on ClinicalTrials.gov — NCT05287841
Locations in the U.S.
| Missouri | Poplar Bluff Regional Medical Center, Poplar Bluff (Not yet recruiting) |
| New York | Lenox Hill Hospital/Staten Island University Hospital, New York Staten Island University Hospital, Staten Island |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.