Lateral Crural Strut Graft vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Lateral Crural Strut Graft
Lateral crura strut graft is a well described and universally used technique involves strengthening lateral crus of lower lateral cartilage of the nose with piece of cartilage.
干预措施: Lateral Crural Strut Graft (Procedure)
Bone-Anchored suspension
Bone- Anchored suspension is a well described surgical technique which involves anchoring the nasal sidewall to the bony rim below the eye.
干预措施: Bone Anchored Suspension (Procedure)
结局指标
主要结局
NOSE (Nasal Obstruction Symptom Evaluation)score change from baseline to 12 months post op
时间窗: 1 year
Nasal Obstruction Symptom Evaluation (NOSE) scale is a validated disease-specific questionnaire for the assessment of Nasal Obstruction (NO)
次要结局
- Visual analogue scale for satisfaction with appearance of the nose(1 year)
- Visual Analogue Scale for nasal obstruction(1 year)
- physician derived lateral wall insufficiency grading system(1 year)
研究者
Sam P. Most
Division of Facial Plastic and Reconstructive Surgery
Stanford University