RecruitingNot Applicable

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

United States96 participantsStarted 2021-04-30

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

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

What they're measuring

Nasal Obstruction Symptom Evaluation (NOSE) score

Timeframe: 12 months

Trial details

NCT IDNCT05287841

SponsorNorthwell Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Research Department

718-226-6256 SIUHResearch@northwell.edu

View on ClinicalTrials.gov More Nasal Obstruction trials