Analyzing Anesthetic Techniques in Diabetic Foot Amputation
NCT Number: NCT06552910
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Diabetic Foot|Amputation, Surgical
Interventions: PROCEDURE: Nerve Block
Sponsor: Ankara City Hospital Bilkent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 450
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-01
Completion Date: 2024-12-30
Locations: Semih Başkan, Etimesgut, Ankara, 06790, Turkey

Summary:
Diabetic Foot Amputations: A Comprehensive Review of Anesthetic Procedures and Outcomes

Introduction:

Diabetic foot is a severe complication of diabetes, often resulting in ulceration, osteomyelitis, and gangrene. Amputation or surgical debridement is the standard treatment for advanced cases. The study aims to evaluate the outcomes of different anesthetic techniques in diabetic foot amputation, specifically comparing peripheral nerve block (PNB) and general anesthesia.

Objective:

To assess the impact of anesthetic procedures on outcomes in diabetic foot amputation cases using inpatient data. The hypothesis is that PNB will result in fewer postoperative complications than general anesthesia-primary outcome: 30-day mortality; secondary outcomes: composite morbidity and hospital discharge duration.

Materials and Methods:

This retrospective chart review will analyze medical records of patients with diabetic foot at Ankara Bilkent City Hospital from 2021 to 2023. Inclusion criteria: patients who underwent toe, ankle, or foot amputations. Exclusion criteria: patients under 18, amputations for non-diabetic reasons, and insufficient medical data. Data will include patient demographics, preoperative medications, comorbidities, and surgical details. Major complications, secondary outcomes, and mortality will be primary measures.

Statistical Analysis:

Descriptive statistics will summarize patient characteristics. Chi-square and Student t-tests will analyze associations between anesthesia type and postoperative outcomes. Kaplan-Meier survival analysis will compare hospital stay durations. Logistic regression will adjust for confounders and assess the impact of anesthetics on complications. Results will be significant at p \< 0.05.

Primary Outcome Measures: 30-Day Mortality Rate in Patients Undergoing Diabetic Foot Amputation, This study aims to evaluate the 30-day mortality rate in patients undergoing diabetic foot amputation. Mortality rate is defined as the occurrence of death within 30 days following surgery. The primary focus is to compare the short-term survival effects of different anesthesia techniques (general anesthesia and peripheral nerve block) on these patients., Time Frame: 30 days post-surgery.
Secondary Outcome Measures: Composite Morbidity from Potentially Fatal Sequelae, This secondary outcome measure evaluates the occurrence of composite morbidity resulting from potentially fatal sequelae in patients undergoing diabetic foot amputation. This includes major complications such as pneumonia, myocardial infarction, stroke, venous thromboembolism, delirium, acute kidney injury, new requirement for dialysis, surgical site infection, and re-operation. The aim is to assess how different anesthesia techniques impact the rate and severity of these complications., From the date of surgery until hospital discharge, assessed up to 3 months.|Hospital Discharge Duration, This secondary outcome measure focuses on the length of hospital stay following diabetic foot amputation. It aims to determine whether the type of anesthesia used (general anesthesia or peripheral nerve block) influences the duration of hospitalization, thereby providing insights into recovery times and healthcare resource utilization., From the date of surgery until hospital discharge, assessed up to 3 months.