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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Missouri
Poplar Bluff Regional Medical Center
NOT_YET_RECRUITING
Poplar Bluff
New York
Lenox Hill Hospital/Staten Island University Hospital
RECRUITING
New York
Staten Island University Hospital
RECRUITING
Staten Island
Contact Information
Primary
Research Department
SIUHResearch@northwell.edu
718-226-6256
Backup
David Hiltzik, MD
dhiltzik1@northwell.edu
212-434-4500
Time Frame
Start Date: 2021-04-30
Estimated Completion Date: 2025-06-15
Participants
Target number of participants: 96
Treatments
Experimental: Batten graft, plus septoplasty and inferior turbinate reduction
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.
Active_comparator: Septoplasty and inferior turbinate reduction alone
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.
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov