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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05598385
Acronym
ProGlide-II
Enrollment
0
Registered
2022-10-28
Start date
2024-11-30
Completion date
2024-11-09
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Peripheral cannulation, Open cannulation, Percutaneous cannulation, Minimally invasive cardiac surgery

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.

Interventions

PROCEDUREOpen cannulation

A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.

PROCEDUREPercutaneous cannulation

Cannulation is performed through a suture-mediated closure system.

Sponsors

Jessa Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with groin complicationsUntil 30 days postoperativelyGroin 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026