Post-marketing, Observational Study of ALTUS Powered Stapler Used in Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Safety - Number of reinterventions
研究概览
简要总结
Post-marketing, observational study to evaluate the safety and performance of the ALTUS Powered Stapler in bariatric surgery of "real-world" patients.
详细描述
Up to 300 patients who underwent sleeve, bypass or revisional bariatric surgery with the use of Altus Powered Stapler will be included in the study. The stapler should be used according to the Instructions for Use and according to the local practice.
The Altus Powered Stapler is used in open or laparoscopic surgeries and simultaneously cuts and staples soft tissues. In order to avoid great physical efforts by the physician and ensure excellent tissue suturing, the cutting and stapling mechanism is driven by the 12-volt battery that comes with the stapler.
Patients will be followed by 7, 30 and 90 days and 12 months after the procedure, as per the research center's standard routine.
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
- •Patients with grade II obesity (BMI ≥ 35 kg/m^2) with one or more associated comorbidities;
- •Patients with grade III obesity (BMI ≥ 40 kg/m^2) regardless of associated diseases;
- •Patients who underwent sleeve, bypass and revisional bariatric surgery procedure with use of the Altus Powered Stapler;
- •The patient must sign and date the informed consent form during a routine follow-up visit, authorizing the use of their surgery data and contact for follow-up.
排除标准
- •Impossibility of collecting data related to the surgical procedure
- •Impossibility of contact with the patient to obtain the informed consent form
结局指标
主要结局
Safety - Number of reinterventions
时间窗: Up to 1 week
Number of reinterventions within 1 week after the procedure
Safety - Postoperative anastomotic leaking and intraluminal/intraperitoneal bleeding
时间窗: 30 days
Presence of complications of anastomotic leaking and intraluminal/intraperitoneal bleeding within 30 days after procedure
Safety- Fistula formation
时间窗: 30 days
Presence of fistula within 30 days after procedure
Safety - Stenosis
时间窗: 90 days
Detection of stenosis within 90 days after procedure
Performance - Procedure Success
时间窗: Intraoperative
Defined by completion of technique with the device for its intended use
Performance - Cicatrization of staple line
时间窗: 90 days
The absence of oozing/bleeding at the staple line
Safety - Conversion to open surgery
时间窗: Intraoperative
Number of conversions to open surgery during the index procedure
次要结局
- Post-operative change in weight(12 months)