Improving Hemostasis in Sleeve Gastrectomy With Alternative Stapler
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Staple Line Bleeding
研究概览
简要总结
The goal of this prospective, multi-center, post-market study is to measure AEON™ Endostapler performance with the EASY/THICK MODE feature for laparoscopic bariatric surgery against the Echelon Flex™ Powered Stapler system from Ethicon. Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding through a third-party blinded primary outcome evaluator. The study will include 60 total consecutive cases of individuals undergoing a planned laparoscopic sleeve gastrectomy (LSG). The LSG procedure will be performed according to institutional standard-of-care and all subjects will undergo standard preoperative evaluation as well as post-operative care. Relevant data will be collected using the Data Collection sheet which should be filled out following each procedure by a member of the surgical or nursing team.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Patients undergoing planned laparoscopic sleeve gastrectomy with signed surgery consent form
- •Informed consent for study obtained and signed from each subject
排除标准
- •Planned open surgical approach
- •Prior bariatric operation (i.e. revisional bariatric surgery)
- •Use of staple line reinforcement material (buttress)
- •Patients taking anticoagulants
- •Patients under the age of 18 on the date of the surgery
结局指标
主要结局
Staple Line Bleeding
时间窗: 10 seconds after last staple line
Intraoperative staple line bleeding as measured by the provided bleeding severity scale (1: No bleeding; 2: Minimal bleeding; 3: Moderate bleeding; 4: Excessive bleeding; 5: Profuse bleeding)
次要结局
- Staple Line Leaking(1 month following procedure)
- Blood Transfusion(Within 72 hours of surgery start)
- Pain Level(1 week following procedure)
- Adverse Events(1 month following procedure)
- Product Malfunction(During surgery)