Groin Complications in Open Vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 200
- 主要终点
- Number of participants with groin complications
研究概览
简要总结
The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery
详细描述
The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).
Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •>18 years
- •Patients undergoing elective endoscopic cardiac surgery
排除标准
- •Patients that do no understand Dutch, French, or English
- •Heavily calcified cannula introduction site
- •Central cannulation
研究组 & 干预措施
Percutaneous cannulation
Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.
干预措施: Percutaneous cannulation (Procedure)
Open cannulation
Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.
干预措施: Open cannulation (Procedure)
结局指标
主要结局
Number of participants with groin complications
时间窗: Until 30 days postoperatively
Groin complications consist of groin-related bleeding, dissection, pseudoaneurysm, seroma, infection of the groin, artery occlusion, and reintervention in the groin. Groin complications are diagnosed by an ultrasound.
次要结局
未报告次要终点