Groin Complications in Open vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Groin Complications in Open vs. Percutaneous Peripheral Cannulation for Cardiopulmonary Bypass in Minimally Invasive Cardiac Surgery

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: Open cannulation
* Procedure: Percutaneous cannulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous cannulation<br>Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. | Procedure: Percutaneous cannulation<br>* Cannulation is performed through a suture-mediated closure system.<br>|
| Active Comparator: Open cannulation<br>Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation. | Procedure: Open cannulation<br>* A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral cannulation, Open cannulation, Percutaneous cannulation, Minimally invasive cardiac surgery