NCT07071740已完成不适用
Robotic Minimally Invasive Ventral Hernia Repair With DEXTER
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- Primary safety 0utcome
研究概览
简要总结
The aim of this clinical investigation is to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing incisional or primary ventral 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
- •Planned to undergo incisional and primary midline ventral (M2-M4; epigastric, umbilical and infraumbilical) hernia repair smaller and equal to 8cm
- •Patient agrees to perform the 30-day follow-up assessment, as per standard of care
排除标准
- •Any planned concomitant procedures
- •Active anticoagulant treatment
- •Recurring hernia with mesh during primary hernia repair
- •Need for transversal abdominal release
- •Patients under corticosteroids or other immunosuppressive treatment
- •Loss of domain type of hernia
- •Previous incision extending from xiphoid process to pubic bone (= Median laparotomy M1 to M5)
- •M2 hernia extending to M1 and/or M4 hernia extending to M5
- •Ongoing intra-abdominal infection or septic state
- •Abdominal fistulae
- •History of major* abdominal or pelvic surgery
结局指标
主要结局
Primary safety 0utcome
时间窗: up to 30 days after surgery
Occurrence of Clavien-Dindo grades III-V adverse events
Primary efficacy outcome
时间窗: Intraoperative
Successful completion of the DEXTER-assisted procedure, i.e. free of any conversion to an open or fully laparoscopic surgical approach
次要结局
未报告次要终点
研究者
研究点 (5)
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