Robotic Versus Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
Sleeve gastrectomy is the most commonly performed bariatric procedures. Robotic surgery seems to add more precision to the surgical interventions. However, robotic bariatric procedures appear to be burdened by longer operative time.
Aim of the investigators is to prospectively and randomly submit patients suffering from obesity to robotic or laparoscopic surgery in order to compare outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •According to IFSO (International Federation for the Surgery of Obesity)/ASMBS (American Society for Metabolic and Bariatric Surgery) 2023 guidelines
排除标准
- •Previous bariatric or abdominal surgery
研究组 & 干预措施
Laparoscopic sleeve gastrectomy
Patients undergoing traditional sleeve gastrectomy
干预措施: Sleeve gastrectomy (Procedure)
Robotic sleeve gastrectomy
Sleeve gastrectomy with DaVinci robot
干预措施: Sleeve gastrectomy (Procedure)
结局指标
主要结局
Operative time
时间窗: From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich
Operative time in minutes (Docking plus console time for the robotic procedures)
次要结局
- Intraoperative bleeding(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Postoperative bleeding(From the end of the procedure to postoperative day 30)
- Conversion to Laparoscopy(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Conversion to Laparotomy(From the Veress needle insertion at the beginning of the surgical intervention to the last skin stich)
- Postoperative Leak(From the end of the procedure to postoperative day 30)
- Postoperative Bowel Obstruction(From the end of the procedure to postoperative day 30)
- Postoperative nausea(From the end of the procedure to postoperative hour 24)
- Postoperative vomit(From the end of the procedure to postoperative hour 24)
研究者
Antonio Vitiello
MD PhD Researcher
University of Naples