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.

Study Overview

• Status: Completed
• Conditions: Child Health; Bypass Graft Occlusion
• Intervention / Treatment: Procedure: pediatric vascular bypass grafting

• Study Type: Observational
• Enrollment (Actual): 27

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study represents a retrospective cohort analysis of pediatric patients who underwent vascular bypass grafting by an experienced team of vascular surgeons at the Medical University Vienna between 2002-2017.

All data regarding demographics, operative techniques and outcome were collected from the in-hospital database registry in collaboration with the Department of Orthopedics and Trauma-Surgery. All patients ≤ 18 years who suffered a traumatic injury or vascular surgery due to a planned orthopedic extremity tumor resection were included in this study. 33 patients underwent vascular repair, a total of 15 patients fulfilling the criteria could be identified.

Description

Inclusion Criteria:

• age <18 years
• planned vascular bypass grafting

Exclusion Criteria:

• age >18 years
• no vascular intervention

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
orthopedic surgery group; Planned tumor resection	Procedure: pediatric vascular bypass grafting; pediatric vascular bypass grafting
traumatic surgery group; Patients with traumatic vascular injury	Procedure: pediatric vascular bypass grafting; pediatric vascular bypass grafting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bypass growth	bypass growth	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
autologous vs. PTFE graft	patients will either receive an autologous bypass graft or PTFE graft	patency rate in 1 year
revision surgery	revision surgery	<30 days

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2002
• Primary Completion (Actual): January 30, 2017
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1025/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No