Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552910
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Analyzing Anesthetic Techniques in Diabetic Foot Amputation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diabetic Foot Amputations A Comprehensive Review of Anesthetic Procedures and Outcomes
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 005
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 005
Detailed Description:
Diabetic Foot Amputations A Comprehensive Review of Anesthetic Procedures and Outcomes Introduction Diabetic foot is a clinical manifestation of diabetes with a wide range of symptoms including ulceration osteomyelitis osteoarticular destruction and gangrene as a consequence of advanced disease Some cases of diabetic foot present general indications for amputation including dead limbs threat to the patients life pain loss of function or nuisance Surgical debridement or amputation is the standard treatment for this condition Multiple debridement operations however have been shown in recent research to considerably improve wound healing rates making them a potential therapeutic alternative The majority of patients with diabetic foot ulcers are older have had diabetes for a longer period have numerous organ problems and at least one comorbid ailment
As neuraxial anesthesia a type of regional anesthetic does not require positive mechanical breathing and offers superior pain management less surgical stress response and enhanced blood flow it should theoretically result in a better prognosis than general anesthesia However due to the increased incidence of macrovascular complications such as peripheral artery occlusive disease cerebrovascular disease and coronary heart disease in patients undergoing diabetic foot amputation prophylactic or therapeutic anticoagulation is necessary On the other hand peripheral nerve block PNB shares many theoretical advantages of regional anesthesia and can be beneficial in these cases
The goal of the research is to assess the outcomes of anesthetic procedures carried out in diabetic foot amputation cases using data from an inpatient database The hypothesis is that peripheral nerve block will be less likely than general anesthesia to cause postoperative complications The primary outcome is 30-day mortality following lower extremity amputation secondary outcomes include composite morbidity from potentially fatal sequelae and hospital discharge duration
Materials and Methods This study will be conducted using a retrospective chart review method The study will utilize data from the medical records of patients Medical data from patients with diabetic foot at Ankara Bilkent City Hospital between 2021 and 2023 will be included in the study These patients will include those who have toe ankle or foot amputations This research will encompass all individuals who had surgery during this time Patients with diabetic feet who had their feet ankles or toes amputated will meet the inclusion criteria Exclusion criteria will include those under the age of 18 those whose amputations were performed for reasons other than diabetic foot and those with insufficient medical data
Since this study will be conducted retrospectively the choice of anesthesia method was based on clinical experience
Using the hospital information management system patients medical records will be examined retrospectively Baseline patient demographic data will include age sex height weight body mass index nature of the procedure smoking status and American Society of Anesthesiologists physical status classification Preoperative medication records will be gathered including beta-blockers calcium channel blockers insulin renin-angiotensin system antagonists anticoagulant or antiplatelet medicines and HMG-CoA reductase inhibitors The patients comorbidities will also be collected including the presence of a wound infection bleeding disorders sepsis and whether the surgery was an emergency Additionally the history of diabetes the number of pack-years of smoking and histories of chronic obstructive pulmonary disease congestive heart failure coronary artery disease chronic kidney disease and steroid dependence will be documented Preoperative values of hematocrit hemoglobin platelets creatinine and albumin will be collected along with details of the type of anesthesia general spinal or epidural length of surgery intraoperative blood loss postoperative pain ratings and complications
Major complications will include pneumonia as defined by the European Perioperative Clinical Outcome guidelines myocardial infarction as defined by the World Health Organization stroke defined as a central neurologic deficit persisting postoperatively for more than 24 hours venous thromboembolism confirmed on imaging delirium confirmed by a psychiatrist acute kidney injury as defined by the Kidney Disease Improving Global Outcomes Criteria new requirement for dialysis surgical site infection and re-operation Secondary outcomes and mortality will be the primary outcome measures
Statistical Analysis Descriptive statistics will be employed to summarize the demographic and clinical characteristics of the patients The association between the type of anesthesia used and postoperative outcomes will be analyzed using the Chi-square test for categorical variables and the Students t-test for continuous variables Kaplan-Meier survival analysis will be conducted to estimate survival rates and compare durations of hospital stays between patients receiving different types of anesthesia Logistic regression will be used to adjust for potential confounders and assess the impact of anesthetic techniques on postoperative complications Results will be considered statistically significant at a p-value of less than 005 All statistical analyses will be performed using the hospital information management system
As neuraxial anesthesia a type of regional anesthetic does not require positive mechanical breathing and offers superior pain management less surgical stress response and enhanced blood flow it should theoretically result in a better prognosis than general anesthesia However due to the increased incidence of macrovascular complications such as peripheral artery occlusive disease cerebrovascular disease and coronary heart disease in patients undergoing diabetic foot amputation prophylactic or therapeutic anticoagulation is necessary On the other hand peripheral nerve block PNB shares many theoretical advantages of regional anesthesia and can be beneficial in these cases
The goal of the research is to assess the outcomes of anesthetic procedures carried out in diabetic foot amputation cases using data from an inpatient database The hypothesis is that peripheral nerve block will be less likely than general anesthesia to cause postoperative complications The primary outcome is 30-day mortality following lower extremity amputation secondary outcomes include composite morbidity from potentially fatal sequelae and hospital discharge duration
Materials and Methods This study will be conducted using a retrospective chart review method The study will utilize data from the medical records of patients Medical data from patients with diabetic foot at Ankara Bilkent City Hospital between 2021 and 2023 will be included in the study These patients will include those who have toe ankle or foot amputations This research will encompass all individuals who had surgery during this time Patients with diabetic feet who had their feet ankles or toes amputated will meet the inclusion criteria Exclusion criteria will include those under the age of 18 those whose amputations were performed for reasons other than diabetic foot and those with insufficient medical data
Since this study will be conducted retrospectively the choice of anesthesia method was based on clinical experience
Using the hospital information management system patients medical records will be examined retrospectively Baseline patient demographic data will include age sex height weight body mass index nature of the procedure smoking status and American Society of Anesthesiologists physical status classification Preoperative medication records will be gathered including beta-blockers calcium channel blockers insulin renin-angiotensin system antagonists anticoagulant or antiplatelet medicines and HMG-CoA reductase inhibitors The patients comorbidities will also be collected including the presence of a wound infection bleeding disorders sepsis and whether the surgery was an emergency Additionally the history of diabetes the number of pack-years of smoking and histories of chronic obstructive pulmonary disease congestive heart failure coronary artery disease chronic kidney disease and steroid dependence will be documented Preoperative values of hematocrit hemoglobin platelets creatinine and albumin will be collected along with details of the type of anesthesia general spinal or epidural length of surgery intraoperative blood loss postoperative pain ratings and complications
Major complications will include pneumonia as defined by the European Perioperative Clinical Outcome guidelines myocardial infarction as defined by the World Health Organization stroke defined as a central neurologic deficit persisting postoperatively for more than 24 hours venous thromboembolism confirmed on imaging delirium confirmed by a psychiatrist acute kidney injury as defined by the Kidney Disease Improving Global Outcomes Criteria new requirement for dialysis surgical site infection and re-operation Secondary outcomes and mortality will be the primary outcome measures
Statistical Analysis Descriptive statistics will be employed to summarize the demographic and clinical characteristics of the patients The association between the type of anesthesia used and postoperative outcomes will be analyzed using the Chi-square test for categorical variables and the Students t-test for continuous variables Kaplan-Meier survival analysis will be conducted to estimate survival rates and compare durations of hospital stays between patients receiving different types of anesthesia Logistic regression will be used to adjust for potential confounders and assess the impact of anesthetic techniques on postoperative complications Results will be considered statistically significant at a p-value of less than 005 All statistical analyses will be performed using the hospital information management system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None