Clinical trial NCT05287841: 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
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Obstruction
Septal Defect
Allergic Rhinitis
Nasal Polyps
Nasal Valve Collapse
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nasal Obstruction Symptom Evaluation (NOSE) score
timeFrame: 12 months
Secondary outcomes:
measure: Lateral Wall Insufficiency (LWI) scores
timeFrame: 12 months
measure: Peak Inspiratory Flow Rate (PIFR)
timeFrame: 12 months
measure: Complications and side-effects
timeFrame: 12 months
measure: Cost-effectiveness (EQ-5D-5L)
timeFrame: 12 month
measure: Reoperation incidence
timeFrame: 12 months
Other outcomes:
Locations:
city: Poplar Bluff
country: United States
facility: Poplar Bluff Regional Medical Center
state: Missouri
city: New York
country: United States
facility: Lenox Hill Hospital/Staten Island University Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: David Hiltzik, MD
role: PRINCIPAL_INVESTIGATOR
References: