Clinical Trial

Analyzing Anesthetic Techniques in Diabetic Foot Amputation

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Record status
This record was last updated September 5, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-10.
Trial Details
NCT Number NCT06552910
Lead Sponsor Ankara City Hospital Bilkent
Conditions Diabetic Foot, Amputation, Surgical
Enrollment 450 participants
Start Date 2024-07-01
Primary Completion 2024-12-01 (estimated)
Study Completion 2024-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-05