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After the passing of the principal investigator, the clinical trial could not be started.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous cannulation | Active Comparator | Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. |
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| Open cannulation | Active Comparator | Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open cannulation | Procedure | A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with groin complications | 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. | Until 30 days postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaaddin Yilmaz, MD | Jessa Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Percutaneous cannulation | Procedure | Cannulation is performed through a suture-mediated closure system. |
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