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NCT05598385 Clinical Trial

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

Cardiovascular Diseases Clinical Trial

— ProGlide-II  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05598385
Other study ID # 2022/148
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 14, 2024
Est. completion date January 31, 2026

Study information
Verified date March 2024
Source Jessa Hospital
Contact Alaaddin Yilmaz, MD
Phone 011 33 71 04
Email alaaddin.yilmaz@jessazh.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date January 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Open cannulation
A small incision is made to access the FA and FA. Afterwards, the incision site is traditionally closed with sutures.
• Percutaneous cannulation
Cannulation is performed through a suture-mediated closure system.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jessa Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary 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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