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

Description

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.

Conditions

Nasal Obstruction, Septal Defect, Allergic Rhinitis, Nasal Polyps, Nasal Valve Collapse

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Study Overview

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Study Details

Study 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.

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

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

Condition
Nasal Obstruction
Intervention / Treatment

-

Contacts and Locations

Poplar Bluff

Poplar Bluff Regional Medical Center, Poplar Bluff, Missouri, United States, 63901

New York

Lenox Hill Hospital/Staten Island University Hospital, New York, New York, United States, 10075

Staten Island

Staten Island University Hospital, Staten Island, New York, United States, 10305

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Northwell Health,

David Hiltzik, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

2025-06-15