Allergic Rhinitis, Nasal Obstruction, Nasal Polyps, Nasal Valve Collapse, Septal Defect
Conditions
Brief 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.
Detailed 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 depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.
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.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
The total number of subjects to be accrued locally is 96. We expect 96 patients to be pre-screened, enrolled (consent obtained), randomized, and complete research procedures. Each arm will have 48 patients. 48 patients in two arms for total of 96 patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 <!-- --> 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Obstruction Symptom Evaluation (NOSE) score | 12 months | 1. The NOSE scale is a scoring scale from 0 to 4 (0 = no problem for quality of life, 4 = a severe problem) under 5 different parameters 2. The sum of 5 different parameters are added up to give a range of possible sums from 0-20. This sum is then multiplied by 5 to give a final score with range 0-100. Ref: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-163 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lateral Wall Insufficiency (LWI) scores | 12 months | Blinded, and derived by independent physician watching recorded videos 2. Grading system for lateral nasal wall collapse (0-100%). (1) Identify the junction of the upper and lower cartilages (black arrow) just above the recurvature of the lower lateral cartilage. (2) Imagine a line parallel to the nasal floor across to the septum. (3) Estimate the degree of collapse during inspiration as a percentage compared with repose. Ref: Tsao GJ, Fijalkowski N, Most SP. Validation of a grading system for lateral nasal wall insufficiency. Allergy Rhinol (Providence) 2013;4:e66-e68 |
| Peak Inspiratory Flow Rate (PIFR) | 12 months | Peak inspiratory flow rate ( PIFR ) is the maximum amount of air that can be inhaled over the time course of 1 deep breath, measured in L/min. This will be measured with a nasal spirometer. |
| Complications and side-effects | 12 months | Measured using the the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Reference https://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm |
| Cost-effectiveness (EQ-5D-5L) | 12 month | EQ-5D-5L is a standardized measure of health-related quality of life and validated for QALYs in rhinology research. Estimated total cost of each treatment arm per patient/Estimated QALY derived from EQ-5D-5L per patient = cost-per-QALY Reference: Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X Qual Life Res 2011 Dec;20(10):1727-1736 |
| Reoperation incidence | 12 months | Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100% |
Countries
United States
Contacts
Primary ContactResearch Department
Backup ContactDavid Hiltzik, MD
Outcome results
None listed