Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04511312
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-07-28
Brief Title:
Management and Outcomes of Perioperative Care Among European Diabetic Patients
Sponsor:
European Society of Anaesthesiology
Organization:
European Society of Anaesthesiology
Study Overview
Official Title:
Management and Outcomes of Perioperative Care Among European Diabetic Patients MOPED A Prospective Observational International Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of diabetes is increasing globally including within Europe There is an estimated 20million diabetic patients in Europe which is likely to increase thereby adding to societal demands on European health services Diabetic patients are more likely to have surgical interventions than the general population There are plausible pathophysiology and clinical mechanisms that diabetics are at increased risk of postoperative complications When postoperative complications occur in the general population they increase mortality or increase risk of major adverse cardiovascular events Myocardial Infarction Cerebrovascular Accident Pulmonary embolism at 30-days and up to one year later In addition diabetes is an independent risk factor for surgical site infections
There is variation in practice guidelines in different countries in the perioperative management of diabetic patients undergoing major surgery but this has not been documented on a large scale Given the multiplicity of guidelines and differing recommendations it is unsurprising that variability of real-world clinical practice with regard to perioperative management of oral antihyperglycemic medications and insulin therapy has been noted in audits such as the National Confidential Enquiry into Patient Outcome and Death NCEPOD
Further although it is recognised that diabetic patients are at increased risk of postoperative complications this has not been recently evaluated especially in light of ongoing developments in perioperative care such as Enhanced Recovery Programmes While a quality improvement intervention study has shown that maintaining tight preoperative glycaemic control improves postoperative glycaemic control it is not known if this reduces postoperative morbidity overall Further whether certain anaesthetic techniques may be associated with better or worse outcomes after major non-cardiac surgery is unknown
There is variation in practice guidelines in different countries in the perioperative management of diabetic patients undergoing major surgery but this has not been documented on a large scale Given the multiplicity of guidelines and differing recommendations it is unsurprising that variability of real-world clinical practice with regard to perioperative management of oral antihyperglycemic medications and insulin therapy has been noted in audits such as the National Confidential Enquiry into Patient Outcome and Death NCEPOD
Further although it is recognised that diabetic patients are at increased risk of postoperative complications this has not been recently evaluated especially in light of ongoing developments in perioperative care such as Enhanced Recovery Programmes While a quality improvement intervention study has shown that maintaining tight preoperative glycaemic control improves postoperative glycaemic control it is not known if this reduces postoperative morbidity overall Further whether certain anaesthetic techniques may be associated with better or worse outcomes after major non-cardiac surgery is unknown
Detailed Description:
see brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None