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OpenTrials
Completed

NCT Number: NCT04455373

Long-term Outcome in Pediatric Surgical Bypass Grafting After Traumatic Injury and Tumor Resection

Introduction:

Vascular bypass surgery in children differs significantly from adults. It is a rarely performed procedure in the setting of trauma and tumor surgery to facilitate limb salvage. Beside the technical challenges to reconstruct the small and spastic vessels, bypass grafting should not impede growth of the extremity. The primary aim of this study was to assess long-term outcome after pediatric bypass grafting, in a single academic center, focusing on potential effects on limb development.

Methods:

In this retrospective cohort analyses we included all pediatric patients undergoing vascular bypass grafting at the Medical University of Vienna between 2002-2017. All patients ≤ 18 years suffered a traumatic injury or underwent a tumor resection of the lower or upper limb, respectively. The youngest female patient was 0.4 years, the youngest male patient was 3.5 years.

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Key information

Age range

2 month–18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age <18 years
  • planned vascular bypass grafting

Exclusion criteria

  • age >18 years
  • no vascular intervention

Treatment and study plan

pediatric vascular bypass grafting

Procedure

pediatric vascular bypass grafting

Primary outcomes

  1. bypass growth

    Time frame: 10 years

    bypass growth

Secondary outcomes

  1. autologous vs. PTFE graft

    Time frame: patency rate in 1 year

    patients will either receive an autologous bypass graft or PTFE graft

  2. revision surgery

    Time frame: <30 days

    revision surgery

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2002
Primary completion
2017
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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