Nasal Valve Incompetence
Conditions
Brief summary
Lateral nasal wall insufficiency is a source of nasal obstruction which plagues many people as the sidewall of the nose collapses due to negative pressure and structural weaknesses of the nose. Bone anchored suture suspension is used by many surgeons to treat it, and involves anchoring the nasal sidewall to the bony rim below the eye. Lateral crura strut graft is another well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage. This study aims to compare the two well known and universally used treatments to each other. Based on expert opinions these procedures are both safe and efficient but given lack of randomized clinical trials comparing these 2 techniques, it is difficult to extrapolate which procedure is superior.
Detailed description
Patients with lateral nasal wall collapse who are eligible for surgical repair will be presented with the opportunity to participate. Once consented, standard pre-operative evaluation will be performed including evaluation of degree of lateral nasal wall collapse. They will also be screened with validated quality of life screening tools for nasal congestion, which include the NOSE scale and a visual analog scale. They will then be randomized to treatment either with Lateral crura strut graft or bone anchored suture suspension, in combination with likely other areas of functional rhinoplasty such as septoplasty and turbinate reduction. All of our patients will be seen 1 week, 2-3 month and 1 year after surgery
Interventions
PROCEDURELateral Crural Strut Graft
surgical technique as described
PROCEDUREBone Anchored Suspension
Surgical technique as described
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\- Eligible subjects with be healthy, adults with lateral nasal wall collapse with or without septal deviation, turbinate hypertrophy, or narrowed internal nasal valve. They must have failed prior medical management with topical nasal steroid or topical or oral antihistamines. They must be able to read, sign, and demonstrate understanding of the research protocol, including agreement to randomization for treatment of their lateral nasal wall collapse
Exclusion criteria
* All subjects shall be excluded with evidence or history of prior rhinoplasty, immunocompromise, smokers, chronic sinusitis, history of radiation to the head and neck, septal perforation, granulomatous disease, or pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op | 1 year | Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale for nasal obstruction | 1 year | The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates more severe symptoms. |
| Visual analogue scale for satisfaction with appearance of the nose | 1 year | The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient's mark was placed. A higher number indicates higher degree of satisfaction |
| physician derived lateral wall insufficiency grading system | 1 year | This is a validated grading system which is measured by physician based on degrees of nasal valve insufficiency |
Countries
United States
Outcome results
None listed