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Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

ConditionsNasal ObstructionSeptal DefectAllergic RhinitisNasal PolypsNasal Valve Collapse
Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Septal deviation must be present on direct or endoscopic examination

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Batten batten graft

    Procedure/Surgery

    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.

  • Septoplasty

    Procedure/Surgery

    A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.

  • Inferior Turbinate Reduction

    Procedure/Surgery

    The bilateral inferior turbinates will be surgically ablated.

Treatment groups

13 Participants
are divided into 2 treatment groups
Group A: Batten graft, plus septoplasty and inferior turbinate reductionExperimental treatment 3 interventions
Group B: Septoplasty and inferior turbinate reduction aloneActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Nasal Obstruction Symptom Evaluation (NOSE) score

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

Time frame
12 months

Secondary outcomes

1

Lateral Wall Insufficiency (LWI) scores

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

Time frame
12 months
2

Peak Inspiratory Flow Rate (PIFR)

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.

Time frame
12 months
3

Complications and side-effects

Measured using the the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Reference https://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm

Time frame
12 months
4

Cost-effectiveness (EQ-5D-5L)

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

Time frame
12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov

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