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NCT Number: NCT05287841

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

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.

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Key information

Conditions

Nasal Obstruction Airway Obstruction Allergic Rhinitis Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nasal Polyps Nasal Valve Collapse Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Septal Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Poplar Bluff Regional Medical Center, Poplar Bluff, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients should satisfy all the following criteria to be considered eligible for randomization:
  • 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.

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  • Septal deviation must be present on direct or endoscopic examination
  • Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
  • Collapse of external nasal valve and/or lateral motion instability must be documented

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  • 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

  • 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
  • Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection

Treatment and study plan

Batten batten graft

Procedure

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

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

Inferior Turbinate Reduction

Procedure

The bilateral inferior turbinates will be surgically ablated.

Primary outcomes

  1. Nasal Obstruction Symptom Evaluation (NOSE) score

    Time frame: 12 months

    • 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

Secondary outcomes

  1. Lateral Wall Insufficiency (LWI) scores

    Time frame: 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

  2. Peak Inspiratory Flow Rate (PIFR)

    Time frame: 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.

  3. Complications and side-effects

    Time frame: 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

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

    Time frame: 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

  5. Reoperation incidence

    Time frame: 12 months

    Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100%

Study contacts

Contact information is provided by the study sponsor or research team.

David Hiltzik, MD

CONTACT

[email protected]

212-434-4500

Research Department

CONTACT

[email protected]

718-226-6256

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 18, 2022
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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