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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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.

Eligibility

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.
    4. Septal deviation must be present on direct or endoscopic examination
    5. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
    6. Collapse of external nasal valve and/or lateral motion instability must be documented
    7. 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 details
    Nasal Obstruction
    Septal Defect
    Allergic Rhinitis
    Nasal Polyps
    Nasal Valve Collapse

NCT05287841

Northwell Health

28 January 2024

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