Safety and Efficacy of Suture-Septoplasty for Chronic, Durable Correction of Nasal Septal Deviation Causing Nasal Obstruction Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) score
研究概览
简要总结
Nasal Septal Deviation (NSD) is one of the most common indications for surgery seen by ENT physicians, however, correction requires open surgery which is associated with several weeks of recovery. The purpose of this study is to elucidate whether a suture-based, minimally invasive technique can be used to safely and effectively address NSD.
详细描述
Nasal obstruction due to structural issues such as nasal septal deviation (NSD) is remarkably common. NSD is caused by warping of the midline cartilage and bone of the septum, which starts between the 2 nostrils, and extends 7 cm posteriorly to the nasopharynx. This crooked or deviated conformation in the nasal septum cartilage and/or bone leads to physical blockade of normal airflow through the nose, often leading to complaints of nasal congestion, sleep disturbance, exercise limitations, and even poor compliance with CPAP mask use for treatment of obstructive sleep apnea (OSA). To correct this structural issue in symptomatic patients, septoplasty surgery under general anesthesia is typically advocated.
As an alternative to standard septoplasty, there are rare reports of simplified suture techniques that may be used to straighten the nasal septal cartilage. However, virtually all published studies to our knowledge have still required 1) some degree of cartilage/bone excision, which can destabilize the nasal support framework, and 2) use of non-locking sutures which can break, provide insufficient support, and be technically challenging given that it requires knot tying within the narrow nasal cavity corridors.
The investigators have demonstrated in benchtop models that similar results to standard septoplasty techniques can may be achieved with the use of a non-retractable suture without the need for cartilage excision. This technique, therefore, could allow for a simple, and knotless, minimally invasive way to improve and/or correct symptomatic NSD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients from all ethnic and geographic backgrounds within the Stanford Sinus Center with symptomatic NSD
- •Primary patients with NSD without past septum surgery
- •Patients who have failed maximum medical therapy
- •Patients whose symptoms, examination and/or imaging findings are sufficiently severe as to warrant septoplasty as determined by the treating surgeon
排除标准
- •Age < 18
- •Recent surgery of any kind (<1 month)
- •Inpatients
- •Previous nasal septum surgery
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) score
时间窗: baseline, month 3
Unabbreviated scale title: Nasal Obstruction Symptom Evaluation. Mean change from baseline. Minimum value = 0, maximum value = 100. Higher score indicates a worse outcome.
次要结局
- Sino-Nasal Outcome Test (SNOT)-22 score(baseline, month 3)
研究者
Jayakar Nayak
Associate Professor of Otolaryngology - Head & Neck Surgery (OHNS) and, by courtesy, of Neurosurgery at the Stanford University Medical Center
Stanford University
