Bariatric, Revisional and General Surgery With Magnetic Assistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Range of surgical time
研究概览
简要总结
Magnetic devices have been successfully used in bariatric surgery. To the date the only reported use of the magnet was for liver retraction. This study is to demonstrate the safety and viability of using the magnetic system as a second surgical assistant in bariatric surgery and not only for liver retraction.
详细描述
Patients undergoing primary laparoscopic sleeve gastrectomy (SG), one-anastomosis gastric bypass (OAGB), and Roux-en-Y gastric bypass (RYGB) or revisional surgery by single-port or port-reduced approach.
Also others procedures like Nissen/Sleeve gastrectomy or general surgery. The magnetic system can be used like a second assistant in the steps of the surgery for example: liver retraction, upper retraction of gallbladder, retraction of the stomach, upper retraction of jejuno-jejunal anastomosis performing a gastric bypass or closing mesenteric defects liker intermesenteric or Petersen´s defect.
Using the single-port device or port-reduced approach to obtain better aesthetic results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients older than 18 years old
- •BMI Greater than 30 kg/m2 (Obesity)
- •Candidate to bariatric surgery
- •Candidate to revisional bariatric surgery
- •Cholecystitis or Gallstones (General Surgery)
排除标准
- •Patients with pacemakers or electromedical implants
- •Uncontrolled metabolic diseases
- •Psychiatric problems
结局指标
主要结局
Range of surgical time
时间窗: 1-2 hours
See if the surgical time is kept normal
Outcomes of magnetic grasper acting like a second assistant
时间窗: 1-2 hours
See if the magnetic system it can be used in any step of the surgery like a second surgical assistant
Rate of surgical complications
时间窗: 1-2 hours
Any complications or adverse event during the surgery
Rate of complications related to the magnetic system
时间窗: 1-2
Any adverse event or complication related to the magnetic system use during the surgery
次要结局
未报告次要终点
研究者
Guillermo Borjas
Director of the International Bariatric and Metabolic Surgery Unit
Unidad Internacional de Cirugia Bariatrica y Metabolica