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Recruiting NCT05287841

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

Trial Parameters

Condition Nasal Obstruction
Sponsor Northwell Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 96
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-04-30
Completion 2024-12-31
Interventions
Batten batten graftSeptoplastyInferior Turbinate Reduction

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.

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 pr

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