Feasibility and Safety of Robotic Bariatric Surgery Using the SenhanceTM Surgical System: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery
研究概览
简要总结
Evaluating feasibility and safety of the Senhance Surgical System with digital laparoscopy in bariatric surgery.
详细描述
The introduction of laparoscopy in bariatric surgery is considered a milestone to improve postoperative outcomes in terms of less complications and shorter hospital stay. Furthermore, conversion into open surgery is associated with higher postoperative morbidity and mortality in bariatric surgery. Nevertheless, the laparoscopic technique has several drawbacks as lack of tactile feedback, limited degrees of freedom of the laparoscopic instruments, bad depth perception and limited field of view and therefore a flat learning curve.
Senhance Surgical System from Asensus Surgical is an innovative robotic technique which presents haptic feedback, an eyetracker system, microinvasive surgery (with 3mm instruments), reusable instruments and a lower docking time when compared to usual robotic systems.
The use of this new technology has not been systematically analysed in bariatric surgery. Nevertheless, its use is expected to be safe and efficient and may also present some advantages over conventional laparoscopic surgery.
The primary endpoint of the study is the safety of this new robotic platform in bariatric surgery (intraoperative complications, postoperative morbidity, and postoperative mortality). Secondary outcome is the feasibility of this new technology in bariatric surgery (docking time, operation time, conversion rate, length of hospital stay, and rehospitalisation rate).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
- •≥ 18 years old
- •Capable of judgment
- •Patient eligible for laparoscopic bariatric surgery according to the SMOB (Swiss Study Group for Morbid Obesity) -Criteria and having a bariatric operation (including Sleeve gastrectomy, Y-Roux gastric bypass, Omega-loop gastric bypass) using SenhanceTM Surgical System
排除标准
- •< 18 years of age
- •Participants incapable of judgment or participants under tutelage
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •No informed consent signed
- •Women who are pregnant
- •High risk patients (immunosuppression, myopathy, liver cirrhosis, severe heart or lung disease, renal failure)
- •Contra-indication for laparoscopic surgery
- •Prior upper gastro intestinal tract operations (such as hepatobiliary, pancreatic, gastrooesophageal, anti-reflux, bariatric surgery or splenectomy except cholecystectomy) or open surgery with incision above the umbilicus
结局指标
主要结局
Rate of intraoperative organ lesion using the Senhance Surgical System in bariatric surgery
时间窗: During operation, up to 2 hours
Number of patients with intraoperative organ lesion
Rate of intraoperative bleeding using the Senhance Surgical System in bariatric surgery
时间窗: During operation, up to 2 hours
Number of patients with intraoperative bleeding
Rate of postoperative bleeding using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with postoperative bleeding
Rate of thromboembolic complication using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with a thromboembolic complication
Rate of anastomotic or staple line leakage using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with anastomotic or staple line leakage
Rate of surgical site infection using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with surgical site infection (deep or superficial)
Rate of renal complication using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with a renal complication
Rate of cardiovascular complication using the Senhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with a cardiovascular complication
Rate of respiratory complication using theSenhance Surgical System in bariatric surgery
时间窗: up to 30 days postoperatively
Number of patients with a respiratory complication
Rate of procedure interruption using the Senhance Surgical System in bariatric surgery
时间窗: During operation, up to 2 hours
Number of patients with procedure interruption
次要结局
- Feasibility of the Senhance Surgical System in bariatric surgery(up to 30 days postoperatively)