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

Completed

• Conditions: Bypass Graft Occlusion; Child Health
• Interventions: Procedure: pediatric vascular bypass grafting

• Registration Number: NCT04455373
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01-01
• Primary Completion: 2017-01-30
• Study Completion: 2020-02-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• age <18 years
• planned vascular bypass grafting

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Exclusion Criteria

• age >18 years
• no vascular intervention

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
traumatic surgery group	pediatric vascular bypass grafting	Patients with traumatic vascular injury
orthopedic surgery group	pediatric vascular bypass grafting	Planned tumor resection

Primary Outcome Measures

Name	Time	Method
bypass growth	10 years	bypass growth

Secondary Outcome Measures

Name	Time	Method
revision surgery	<30 days	revision surgery
autologous vs. PTFE graft	patency rate in 1 year	patients will either receive an autologous bypass graft or PTFE graft