Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
Northwell Health
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.
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 septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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 <!-- -->…
Interventions
- ProcedureBatten batten graft
The batten grafts are autologous grafts from the patients' own tissue, produced from nasal septal quadrangular cartilage. This will be obtained during the septoplasty portion of the procedure. The batten graft will be used to stabilize the internal nasal valve and prevent nasal valve collapse on inspiration.
- ProcedureSeptoplasty
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
- ProcedureInferior Turbinate Reduction
The bilateral inferior turbinates will be surgically ablated.
Locations (3)
- Poplar Bluff Regional Medical CenterPoplar Bluff, Missouri
- Lenox Hill Hospital/Staten Island University HospitalNew York, New York
- Staten Island University HospitalStaten Island, New York