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

Last updated: September 18, 2024
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasal Obstruction

Allergy

Polyps

Treatment

Batten batten graft

Inferior Turbinate Reduction

Septoplasty

Clinical Study ID

NCT05287841
21-0204
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients should satisfy all the following criteria to be considered eligible forrandomization:
  1. Be age 18 or above

  2. Able to provide written informed consent

  3. Have an indication for batten graft, septoplasty and turbinate reductionaccording to prevailing surgical practices.

  4. Septal deviation must be present on direct or endoscopic examination

  5. Inferior turbinate hypertrophy must be present, direct examination orendoscopic examination

  6. Collapse of external nasal valve and/or lateral motion instability must bedocumented

  7. The ENV maye be assessed clinically by observing the alar collapse at baselineor 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

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 bullosaresection

Study Design

Total Participants: 96
Treatment Group(s): 3
Primary Treatment: Batten batten graft
Phase:
Study Start date:
April 30, 2021
Estimated Completion Date:
June 15, 2025

Study 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.

Connect with a study center

  • Poplar Bluff Regional Medical Center

    Poplar Bluff, Missouri 63901
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Lenox Hill Hospital/Staten Island University Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Active - Recruiting

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