Groin Complications in Open Vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Enrollment
- 200
- Primary Endpoint
- Number of participants with groin complications
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>18 years
- •Patients undergoing elective endoscopic cardiac surgery
Exclusion Criteria
- •Patients that do no understand Dutch, French, or English
- •Heavily calcified cannula introduction site
- •Central cannulation
Arms & Interventions
Percutaneous cannulation
Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.
Intervention: Percutaneous cannulation (Procedure)
Open cannulation
Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.
Intervention: Open cannulation (Procedure)
Outcomes
Primary Outcomes
Number of participants with groin complications
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported