Cost Analysis of Vascular Surgical Techniques

Cost Analysis of Vascular Surgical Techniques: Comparing Limb Revascularisation and Amputation in Patients With CLTI at University Hospital Limerick

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.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia

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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Ireland
  • Munster
    • Limerick, Munster, Ireland
      • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have been diagnosed with CLTI and are under the care of a Vascular Surgeon at University Hospital Limerick

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.	A comparative assessment of the cost implications of the surgical modalities used in the treatment of CLTI i.e., revascularisation and amputation.	2 years

Collaborators and Investigators

• Sponsor: University Hospital of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): March 1, 2024

Study Registration Dates

• First Submitted: April 11, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: DVS010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This project has been written up for submission to an Irish Medical Journal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No