NCT01584193
Withdrawn
Not Applicable
Ultrasound-guided Subclavian Vein Puncture Versus Cephalic Vein Dissection for Totally Implantable Venous Access Port Implementation: a Single-center Controlled Randomized Superiority Trial
University of Lausanne Hospitals1 site in 1 countryJune 2013
ConditionsVascular Surgical Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Surgical Procedures
- Sponsor
- University of Lausanne Hospitals
- Locations
- 1
- Primary Endpoint
- surgical procedure time
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to compare two different surgical techniques for implementation of totally implantable central venous access ports. Ultrasound-guided suclavian vein puncture is compared to cephalic vein dissection.
Investigators
Nicolas DEMARTINES
Professor
University of Lausanne Hospitals
Eligibility Criteria
Inclusion Criteria
- •Age \> 18
- •Informed consent
- •Need for central venous access port implementation under local anesthesia
Exclusion Criteria
- •Impaired blood clotting
- •Ongoing antiplatelet drugs therapy, except acetylsalicylic acid
- •Trauma or surgical past history on both shoulder girdles
- •Known central venous thrombosis (subclavian vein, upper vena cava)
- •Known pneumothorax
- •Septic state
- •Agranulocytosis
Outcomes
Primary Outcomes
surgical procedure time
Time Frame: during surgical procedure
Secondary Outcomes
- technique conversion rate and causes(during surgical procedure)
- primary implementation success rate(during surgical procedure)
- Pain at 30 days(30 days post-procedure)
- Complications rate at 30 days(30 days post-procedure)
- pain during surgical procedure(during surgical procedure)
- pain at 5 days(5 days post-procedure)
- overall implementation success rate(during surgical procedure)
- Complications rate during surgical procedure(during surgical procedure)
- Complications rate at 5 days(5 days post-procedure)
Study Sites (1)
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