A Comparative Analysis of da Vinci-Assisted and Laparoscopic Duodenal Switch (DS) Bariatric Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,878
- 试验地点
- 1
- 主要终点
- Transfusions (Safety)
研究概览
简要总结
To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S, and One Anastomosis Duodenal Switch/OADS) with laparoscopic approaches using real world data (RWD) from the Premier Healthcare Database (PHD).
详细描述
To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S, and One Anastomosis Duodenal Switch/OADS) with laparoscopic approaches using real world data (RWD) from the Premier Healthcare Database (PHD). The study endpoints include:
Safety Related Outcomes
- Intraoperative Complication Rates
- Transfusion Rates
- 30-Day Post-Operative Complication Rates*
- 30-Day Readmission Rates*
- 30-Day Reoperation Rates*
- 30-Day Mortality*
Effectiveness Related Outcomes
- Conversion Rate to Open Surgery
- Operative Time
- Length of Hospital Stay
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Transfusions (Safety)
时间窗: perioperative
Transfusion Rates Rate of transfusion that occur intraoperatively and postoperatively
30-day Mortality Rate (Safety)
时间窗: Intra-operative to 30-days
Incidence of mortality until 30 days
Conversion rate to open surgery (Effectiveness)
时间窗: Intraoperative
Incidence of conversion to open that occur intraoperatively
30-Day Readmission Rates (Safety)
时间窗: Upto 30 days
Incidence of readmission that occur after discharge
Intraoperative Complication Rates (Safety)
时间窗: Intraoperative
Incidence of complications occuring intraoperatively
30-Day Post-Operative Complication Rates (Safety)
时间窗: Intraoperative to 30-days (from the date of surgery upto 30-days)
Incidence of complications that occur after surgery to 30-days
30-Day Reoperation Rates (Safety)
时间窗: upto 30 days following the documented date of the surgery
Incidence of reoperations that occur after till 30 days
Operative Time (Effectiveness)
时间窗: Intraoperative
Amount of time it takes to complete the procedure (in min)
Length of hospital Stay (Effectiveness)
时间窗: perioperative
Number of days participant is in the hospital
次要结局
未报告次要终点