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Completed
NCT05287841
Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?
Conditions: Nasal Obstruction, Septal Defect, Allergic Rhinitis, Nasal Polyps, Nasal Valve Collapse
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 13
Sponsor: Northwell Health
Location: Poplar Bluff Regional Medical Center Poplar Bluff Missouri
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 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
Source: ClinicalTrials.gov (NCT05287841). StuddyBuddy aggregates publicly available trial information.