Cost Analysis of Vascular Surgical Techniques

Completed

• Conditions: Critical Limb Ischemia

• Registration Number: NCT06367803
• Lead Sponsor: University Hospital of Limerick

Brief Summary

Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available.

Detailed Description

Surgical interventions for patients with CLTI include endovascular revascularisation, by-pass revascularisation and amputation.

Clinical outcomes vary greatly for each intervention. The 5-year mortality rate for major amputations i.e., below knee (BKA) and above knee (AKA), is reported to range from 30% to 70%, with AKA having the higher rate of mortality. Concomitant Type II diabetes increases these rates of mortality for both AKA and BKA.

Whilst mortality rates are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention.

Study Timeline

• Study Start: 2023-06-01
• Primary Completion: 2023-12-01
• Study Completion: 2024-03-01
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Cases where CLTI was treated surgically by a Vascular Consultant at UHL will be included in this analysis. That being individuals who underwent revascularisation procedures and/or lower limb amputation.
2. This analysis will look at cases from a set time frame, that being 1st March 2022 to 1st March 2023.

Exclusion Criteria

1. Cases where CLTI was treated conservatively/without surgical intervention will not be included.
2. Surgical intervention outside of UHL.
3. Cases that occurred outside of the set timeframe.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.	2 years	A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Munster, Ireland