A Videographic Study to Evaluate the Impact of a Pulsed Firing Technique on Staple Line Interventions in Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 3
- 主要终点
- Occurrence of oozing/bleeding at the staple line
研究概览
简要总结
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
详细描述
Prospective, multi-center study will evaluate a pulsing technique with the ECHELON FLEX GST system for hemostasis at the staple line in laparoscopic sleeve gastrectomy procedures.
Data collected for the study consists of videography imaging and audio. Video recordings (no subject identifiers) will involve the use of two cameras providing:
- Synchronized Internal and external views of devices used, including the hands of the surgeon firing the endocutter; and
- Audio of the procedure to record the motor noise of the device while firing (audio will help identify the surgeon's pulsing technique during the procedure).
Surgeon satisfaction with transection technique will also be collected. Videography will be evaluated for staple line hemostasis and need for surgical intervention at the staple line (defined in Criteria for Evaluation).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to sign a Video, Audio and Digital Data Release consent for participation; and
- •Scheduled for a laparoscopic sleeve gastrectomy procedure.
排除标准
- •Prophylactic use of buttressing material
- •Other staple line reinforcement
结局指标
主要结局
Occurrence of oozing/bleeding at the staple line
时间窗: Intraoperative
Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of oozing/bleeding at the staple line.
Occurence of sugical interventions required to achieve hemostasis at the staple line
时间窗: Intraoperative
Investigate whether use of a prescribed pulsing technique may provide potential reduction in the occurrence of surgical interventions required to achieve hemostasis at the staple line.
次要结局
未报告次要终点