A Randomized Study Comparing Endostaplers in Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraoperative Endoscopic Staple Line Bleeding Score
研究概览
简要总结
The goal of this prospective, post-market study is to measure AEON™ Endostapler performance for laparoscopic sleeve gastrectomy surgery versus the Endo GIA™ Reloads with Tri-Staple™ Technology from Medtronic.
详细描述
Stapler performance will be evaluated primarily by incidence and degree of staple line bleeding from endoscopic images, evaluated by a blinded third-party. 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.
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
- •Informed consent for study obtained and signed from each subject
排除标准
- •Planned open surgical approach
- •Use of staple line reinforcement material (buttress)
- •Revision or other bariatric procedure
- •Patients with a bleeding disorder: known coagulopathy, or Platelets <100,000, or Partial Thromboplastin Time (PTT) >45sec, or Prothrombin Time (PT) >15sec, or International Normalized Ratio (INR) >1.5
- •Patients with active HIV or Hepatitis B
- •Patients under the age of 18 on the date of the surgery
- •Patients who are pregnant
- •Patients using tobacco products within the last 2 weeks prior to surgery date
- •Patients using cortisone or related products within the last 2 weeks prior to surgery date
结局指标
主要结局
Intraoperative Endoscopic Staple Line Bleeding Score
时间窗: Within surgery, after the last stapler firing
Intraoperative staple line bleeding score from endoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
Intraoperative Laparoscopic Staple Line Bleeding Score
时间窗: Within surgery, images captured 10 seconds after the last stapler firing
Intraoperative staple line bleeding score from laparoscopic images as measured by the provided Bleeding Severity Scale (1 = No bleeding; 2 = Minimal bleeding; 3= Moderate bleeding; 4 = Excessive bleeding; 5 = Profuse bleeding). A lower value represents a better outcome.
次要结局
- Number of Participants With Postoperative Leakage Requiring Intervention(Within 30-day post-operative period)
- Number of Participants With Intraoperative or Postoperative Blood Transfusion(Within 72 hours of surgery start time)
- Number of Participants With Reported Device-related Adverse Events(Within 30-day post-operative period)
- Number of Participants With Product Malfunction(Within surgery)