NCT05873582已完成不适用
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
研究概览
简要总结
This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Aged > 18 years
- •Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
- •Able to provide Informed Consent according to local regulation
排除标准
- •Morbidly obese patients (BMI > 40)
- •Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
- •Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
- •Bleeding diathesis
- •Pregnancy
- •Patients with pacemakers or internal defibrillators
- •Any planned concomitant procedures
- •Patient deprived of liberty by administrative or judicial decision or under legal guardianship
- •Participation in another interventional clinical trial
结局指标
主要结局
Safety: occurrence of serious (Clavien - Dindo grades III-V), device-related, adverse events
时间窗: perioperatively up to 30 days
Performance: successful completion of the Dexter-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
时间窗: intraoperative
次要结局
未报告次要终点
研究者
研究点 (3)
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