A Pilot Study of Single-port Robot-assisted Surgery Using da Vinci SP Surgical System for the Surgical Treatment for Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.
详细描述
This study will be conducted in Chang Gung Memorial Hospital at Linkou.
Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.
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
- 否
入选标准
- •Age 18 years or more.
- •OSA with AHI ≥ 15
- •Has failed, refuses, or is unable to tolerate CPAP therapy
- •Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection)
- •ASA physical status classification 1-2 and adequate organ function
- •Patients willing and able to comply with study protocol requirements and follow-up
- •Informed consent
排除标准
- •Mouth opening too narrow for TORS or trismus
- •Betel nut chewing
- •Suspicious cancer diagnosis
- •Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
- •Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue;
- •Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
- •Active infectious disease
- •Can't follow trial-required procedures
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
- •Severe heart disease (NYHA functional class III-IV)
- •Severe lung disease (GOLD Group C-D)
- •Long-term use of anti-coagulant
- •Patients with coagulopathy
- •Emergency surgery
- •Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
- •Subject is pregnant or suspected to be pregnant
结局指标
主要结局
Conversion rate
时间窗: 3 months (+60 days) post-surgery
Success of tongue base resection without conversion to alternative surgery
Apena Hypopnea Index
时间窗: 3 months (+60 days) post-surgery
Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of \< 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.
次要结局
- Multi-level surgery(Intraoperative)
- Operative time(Intraoperative)
- Readmission rate(30 days)
- Snoring Scale(3 months (+60 days) post-surgery)
- Console time(3 months (+60 days) post-surgery)
- Transfusion and estimated blood loss(3 months (+60 days) post-surgery)
- Length of hospital stay(3 months (+60 days) post-surgery)
- Complication rate(30 days)
- Reoperation rate(30 days)
- Perioperative mortality(30 days)
- Volume of resected tissue(3 months (+60 days) post-surgery)
- Pain score(3 months (+60 days) post-surgery)
- Sleepiness Scale(3 months (+60 days) post-surgery)
- Pittsburgh Sleep Quality Index (PSQI)(at 1, 3, 6 months post-surgery)
- Adverse Events(within 3 months (+60 days) post-surgery)