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

NCT04455373 | Completed

• 1 other identifier: 1025/2018
• Study Type: observational
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Health; Bypass Graft Occlusion

Outcome Measures

Primary Outcomes (1)

• bypass growth

  bypass growth

  10 years

Secondary Outcomes (2)

• autologous vs. PTFE graft

  patency rate in 1 year

• revision surgery

  <30 days

Study Arms (2)

orthopedic surgery group

Planned tumor resection

Procedure: pediatric vascular bypass grafting

traumatic surgery group

Patients with traumatic vascular injury

Procedure: pediatric vascular bypass grafting

Interventions

pediatric vascular bypass grafting PROCEDURE

pediatric vascular bypass grafting

orthopedic surgery group; traumatic surgery group

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• age \<18 years
• planned vascular bypass grafting

You may not qualify if:

• age \>18 years
• no vascular intervention

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Long-term outcome in pediatric surgical bypass grafting after traumatic injury and tumor resection

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 2, 2020
• Study Start: January 1, 2002
• Primary Completion: January 30, 2017
• Study Completion: February 1, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share