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

Child Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455373
• Other study ID #: 1025/2018
• Status: Completed
• Start date: January 1, 2002
• Est. completion date: February 1, 2020

Study information

• Verified date: June 2020
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1, 2020
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

Inclusion Criteria:

• age <18 years

• planned vascular bypass grafting

Exclusion Criteria:

• age >18 years

• no vascular intervention

Related Conditions & MeSH terms

• Bypass Graft Occlusion
• Child Health
• Wounds and Injuries

Intervention

Procedure:
• pediatric vascular bypass grafting
pediatric vascular bypass grafting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bypass growth	bypass growth	10 years
Secondary	autologous vs. PTFE graft	patients will either receive an autologous bypass graft or PTFE graft	patency rate in 1 year
Secondary	revision surgery	revision surgery	<30 days