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

Primary Purpose

Nasal Obstruction, Septal Defect, Allergic Rhinitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Batten batten graft
Septoplasty
Inferior Turbinate Reduction
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.
    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.

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

Sites / Locations

  • Poplar Bluff Regional Medical Center
  • Lenox Hill Hospital/Staten Island University HospitalRecruiting
  • Staten Island University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Batten graft, plus septoplasty and inferior turbinate reduction

Septoplasty and inferior turbinate reduction alone

Arm Description

In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.

In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.

Outcomes

Primary Outcome Measures

Nasal Obstruction Symptom Evaluation (NOSE) score
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 Outcome Measures

Lateral Wall Insufficiency (LWI) scores
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
Peak Inspiratory Flow Rate (PIFR)
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.
Complications and side-effects
Measured using the the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Reference https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
Cost-effectiveness (EQ-5D-5L)
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
Reoperation incidence
Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100%

Full Information

First Posted
May 17, 2021
Last Updated
May 23, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT05287841
Brief Title
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Official Title
Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction, Septal Defect, Allergic Rhinitis, Nasal Polyps, Nasal Valve Collapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The total number of subjects to be accrued locally is 96. We expect 96 patients to be pre-screened, enrolled (consent obtained), randomized, and complete research procedures. Each arm will have 48 patients. 48 patients in two arms for total of 96 patients.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Batten graft, plus septoplasty and inferior turbinate reduction
Arm Type
Experimental
Arm Description
In the intervention arm, a portion of the quadrangular cartilage of the nasal septum is also removed, but will be refashioned and re-implanted into the patient as an autologous batten graft. This will be performed together with standard septoplasty and turbinate reduction.
Arm Title
Septoplasty and inferior turbinate reduction alone
Arm Type
Active Comparator
Arm Description
In the control arm, a portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty and turbinate reduction.
Intervention Type
Procedure
Intervention Name(s)
Batten batten graft
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Septoplasty
Intervention Description
A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.
Intervention Type
Procedure
Intervention Name(s)
Inferior Turbinate Reduction
Intervention Description
The bilateral inferior turbinates will be surgically ablated.
Primary Outcome Measure Information:
Title
Nasal Obstruction Symptom Evaluation (NOSE) score
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Lateral Wall Insufficiency (LWI) scores
Description
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
Time Frame
12 months
Title
Peak Inspiratory Flow Rate (PIFR)
Description
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.
Time Frame
12 months
Title
Complications and side-effects
Description
Measured using the the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Reference https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm
Time Frame
12 months
Title
Cost-effectiveness (EQ-5D-5L)
Description
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
Time Frame
12 month
Title
Reoperation incidence
Description
Measured as incidence of any reoperation within study follow-up period (12 months) divided by the number of total enrollees x 100%
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Department
Phone
718-226-6256
Email
SIUHResearch@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
David Hiltzik, MD
Phone
212-434-4500
Email
dhiltzik1@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hiltzik, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poplar Bluff Regional Medical Center
City
Poplar Bluff
State/Province
Missouri
ZIP/Postal Code
63901
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandros Georgolios, MD, FACS
Phone
573-778-2600
Email
ageorgol@hotmail.com
First Name & Middle Initial & Last Name & Degree
McKenna Hawthorne
Phone
573-778-2600
Email
mckennahawthorne20@gmail.com
First Name & Middle Initial & Last Name & Degree
Alexandros Georgolios, MD, FACS
Facility Name
Lenox Hill Hospital/Staten Island University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hiltzik, MD
Phone
718-226-6110
Email
Dhiltzik1@northwell.edu
First Name & Middle Initial & Last Name & Degree
David Hiltzik, MD
First Name & Middle Initial & Last Name & Degree
Tristan Tham, MD
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Hiltzik, MD
Phone
718-226-6110
Email
Dhiltzik1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Shannen Belotte, MBA
Phone
718-226-8559
Email
Sbelotte@Northwell.edu
First Name & Middle Initial & Last Name & Degree
David Hiltzik, MD
First Name & Middle Initial & Last Name & Degree
Tristan Tham

12. IPD Sharing Statement

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

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