NCT04506190已完成不适用
A Prospective Multicenter Study to Evaluate the Perioperative Outcomes of Robotic-assisted Revisional Bariatric Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Rate of conversions
研究概览
简要总结
Very few studies have compared robotic-assisted (RRBS) versus laparoscopic revisional bariatric surgeries (LRBS). To date, there has not been a prospective study comparing the perioperative outcomes of patients undergoing robotic-assisted and laparoscopic revisional bariatric surgery. This study aims to enroll patients undergoing RRBS and LRBS and evaluate the outcomes through 45 days, including the perioperative period. We hypothesize that RRBS may be associated with lower rates of perioperative outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Subject is 18 years or older at the time of consent
- •Subject has a history of prior bariatric surgery
- •Subject's revisional procedure will be either laparoscopic revisional bariatric surgery (LRBS) or robotic-assisted revisional bariatric surgery (RRBS)
- •Subject undergoes revisional bariatric surgery that is applicable to study
排除标准
- •Subject is undergoing a primary bariatric procedure
- •Subject has undergone more than one previous bariatric procedure
- •Subject's revisional bariatric procedure is an emergent procedure
- •Subject is contraindicated for general anesthesia or surgery
- •Subject is unable to comply with the follow-up visit schedule
- •Subject is pregnant or suspects pregnancy
- •Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- •Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
结局指标
主要结局
Rate of conversions
时间窗: During the surgical procedure
Conversions is defined as RRBS to LRBS or open revisional bariatric surgery, and LRBS to open revisional bariatric surgery
次要结局
- Postoperative rate of anastomotic leak(45 days after date of procedure)
研究者
研究点 (1)
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