Improving nasal outcomes with batten grafts during surgery

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

This study is testing if adding batten grafts during nose surgery can help people with nasal blockage breathe better and have longer-lasting results compared to standard surgery alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 3 sites (Poplar Bluff, Missouri and 2 other locations)
• Trial ID: NCT05287841 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of adding batten grafts to standard septoplasty and turbinate reduction procedures for patients with nasal obstruction. Participants will be randomly assigned to receive either the combined treatment with batten grafts or the standard procedure alone. The study will assess both subjective patient-reported outcomes and objective measures of nasal airflow to determine if the addition of batten grafts leads to better long-term results. The goal is to enhance surgical outcomes and potentially reduce the need for future surgeries.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented nasal obstruction due to septal deviation, inferior turbinate hypertrophy, and nasal valve collapse.

Not a fit: Patients without significant nasal obstruction or those who do not meet the specific anatomical criteria for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved breathing and quality of life for patients suffering from nasal obstruction.

How similar studies have performed: While the use of batten grafts in nasal surgery is a recognized technique, the specific combination of this approach with septoplasty and turbinate reduction is less commonly studied, making this a novel investigation.

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.

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  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

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  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

Where this trial is running

Poplar Bluff, Missouri and 2 other locations

• Poplar Bluff Regional Medical Center — Poplar Bluff, Missouri, United States (NOT_YET_RECRUITING)
• Lenox Hill Hospital/Staten Island University Hospital — New York, New York, United States (RECRUITING)
• Staten Island University Hospital — Staten Island, New York, United States (RECRUITING)

Study contacts

• Principal investigator: David Hiltzik, MD — Northwell Health
• Study coordinator: Research Department

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