RECRUITING

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

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Conditions

Nasal ObstructionSeptal DefectAllergic RhinitisNasal PolypsNasal Valve Collapse

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-04-30
Study Completion:2025-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05287841

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients should satisfy all the following criteria to be considered eligible for randomization:
  2. 1. Be age 18 or above
  3. 2. Able to provide written informed consent
  4. 3. Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.
  5. 1. Septal deviation must be present on direct or endoscopic examination
  6. 2. Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
  7. 3. Collapse of external nasal valve and/or lateral motion instability must be documented
  8. 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. 1. Septal perforation
  2. 2. History of previous functional rhinoplasty or sinus or septal surgery
  3. 3. Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
  4. 4. Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
  5. 5. Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection

Contacts and Locations

Study Contact

Research Department
CONTACT
718-226-6256
SIUHResearch@northwell.edu
David Hiltzik, MD
CONTACT
212-434-4500
dhiltzik1@northwell.edu

Principal Investigator

David Hiltzik, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

Poplar Bluff Regional Medical Center
Poplar Bluff, Missouri, 63901
United States
Lenox Hill Hospital/Staten Island University Hospital
New York, New York, 10075
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • David Hiltzik, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-30
Study Completion Date2025-06-15

Study Record Updates

Study Start Date2021-04-30
Study Completion Date2025-06-15

Terms related to this study

Additional Relevant MeSH Terms

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