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

Not Applicable

Withdrawn

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: Open cannulation; Procedure: Percutaneous cannulation

• Registration Number: NCT05598385
• Lead Sponsor: Jessa Hospital

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 Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-26
• Study First Posted: 2022-10-28
• Status Verified: 2024-03
• Study Start: 2024-11
• Primary Completion: 2024-11-09
• Study Completion: 2024-11-09
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open cannulation	Open cannulation	Open peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.
Percutaneous cannulation	Percutaneous cannulation	Percutaneous peripheral cannulation will be applied. An ultrasound is performed preoperative, at discharge and during the follow-up consultation.

Primary Outcome Measures

Name	Time	Method
Number of participants with groin complications	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.