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

NCT05287841 | Recruiting

• 1 other identifier: 21-0204
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Nasal Obstruction Symptom Evaluation (NOSE) score

  1. 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 2. 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

  12 months

Secondary Outcomes (5)

• Lateral Wall Insufficiency (LWI) scores

  12 months

• Peak Inspiratory Flow Rate (PIFR)

  12 months

• Complications and side-effects

  12 months

• Cost-effectiveness (EQ-5D-5L)

  12 month

• Reoperation incidence

  12 months

Study Arms (2)

Batten graft, plus septoplasty and inferior turbinate reduction

EXPERIMENTAL

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.

Procedure: Batten batten graft; Procedure: Septoplasty; Procedure: Inferior Turbinate Reduction

Septoplasty and inferior turbinate reduction alone

ACTIVE COMPARATOR

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.

Procedure: Septoplasty; Procedure: Inferior Turbinate Reduction

Interventions

Batten batten graft PROCEDURE

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.

Batten graft, plus septoplasty and inferior turbinate reduction

Septoplasty PROCEDURE

A portion of the quadrangular cartilage of the nasal septum is removed. This will be performed as a standard septoplasty.

Batten graft, plus septoplasty and inferior turbinate reduction; Septoplasty and inferior turbinate reduction alone

Inferior Turbinate Reduction PROCEDURE

The bilateral inferior turbinates will be surgically ablated.

Batten graft, plus septoplasty and inferior turbinate reduction; Septoplasty and inferior turbinate reduction alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
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• 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
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• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (3)

Poplar Bluff Regional Medical Center

Poplar Bluff, Missouri, 63901, United States

NOT YET RECRUITING

Lenox Hill Hospital/Staten Island University Hospital

New York, New York, 10075, United States

RECRUITING

Staten Island University Hospital

Staten Island, New York, 10305, United States

RECRUITING

MeSH Terms

Conditions

Nasal Obstruction; Heart Septal Defects; Rhinitis, Allergic; Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Rhinitis; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• David Hiltzik, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Department

CONTACT

718-226-6256; SIUHResearch@northwell.edu

David Hiltzik, MD

CONTACT

212-434-4500; dhiltzik1@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: March 18, 2022
• Study Start: April 30, 2021
• Primary Completion: December 31, 2024
• Study Completion: June 15, 2025
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

US (3)