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

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Rhinitis; Nasal Polyps; Nasal Obstruction; Nasal Valve Collapse; Septal Defect
• Intervention / Treatment: Procedure: Batten batten graft; Procedure: Septoplasty; Procedure: Inferior Turbinate Reduction

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Hiltzik, MD; Phone Number: 212-434-4500; Email: dhiltzik1@northwell.edu
• Study Contact Backup: Name: Research Department; Phone Number: 718-226-6256; Email: SIUHResearch@northwell.edu

Study Locations

• United States
  • Missouri
    • Poplar Bluff, Missouri, United States, 63901
      • Not yet recruiting
      • Poplar Bluff Regional Medical Center
      • Contact: Alexandros Georgolios, MD, FACS; Phone Number: 573-778-2600; Email: ageorgol@hotmail.com
      • Contact: McKenna Hawthorne; Phone Number: 573-778-2600; Email: mckennahawthorne20@gmail.com
      • Principal Investigator: Alexandros Georgolios, MD, FACS
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital/Staten Island University Hospital
      • Contact: David Hiltzik, MD; Phone Number: 718-226-6110; Email: Dhiltzik1@northwell.edu
      • Principal Investigator: David Hiltzik, MD
      • Sub-Investigator: Tristan Tham, MD
    • Staten Island, New York, United States, 10305
      • Recruiting
      • Staten Island University Hospital
      • Contact: David Hiltzik, MD; Phone Number: 718-226-6110; Email: Dhiltzik1@northwell.edu
      • Principal Investigator: David Hiltzik, MD
      • Sub-Investigator: Tristan Tham
      • Contact: Shannen Belotte, MBA; Phone Number: 718-226-8559; Email: Sbelotte@Northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Batten graft, plus septoplasty and inferior turbinate reduction; In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.	Procedure: Batten 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.; Procedure: Septoplasty; A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.; Procedure: Inferior Turbinate Reduction; The bilateral inferior turbinates will be surgically ablated.
Active Comparator: Septoplasty and inferior turbinate reduction alone; In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.	Procedure: Septoplasty; A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.; Procedure: Inferior Turbinate Reduction; The bilateral inferior turbinates will be surgically ablated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Obstruction Symptom Evaluation (NOSE) score	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; 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months
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.	12 months
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	12 months
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	12 month
Reoperation incidence	Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100%	12 months

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: David Hiltzik, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 15, 2025

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Respiration Disorders; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Polyps; Respiratory Insufficiency; Airway Obstruction; Rhinitis; Rhinitis, Allergic; Nasal Polyps; Nasal Obstruction
• Other Study ID Numbers: 21-0204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No