Management and Outcomes of Perioperative Care Among European Diabetic Patients

Management and Outcomes of Perioperative Care Among European Diabetic Patients: (MOPED): A Prospective Observational, International Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Diabetes Mellitus

Detailed Description

see brief summary

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: saman Homayun Sepehr, Master; Phone Number: 3222273999; Email: saman.sepehr@esahq.org

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Mater University Hospital
    • Contact: ESAIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

Inclusion Criteria:

• Diabetic patients (all classes except gestational diabetes) undergoing surgery (defined as requiring any general anaesthesia technique or any specific regional anaesthetic technique or a combination)
• Ambulatory, elective or emergency surgery and patients who receive postoperative care in intensive care or high dependency units will be included.

Exclusion Criteria:

• Patients who are not diabetic
• Patients with gestational diabetes
• Patients undergoing minor surgery

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days at Home at 30 Days after surgery (DAH-30)	Number of days at home in the 30 days post surgery	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comprehensive Complications Index (CCI) score, based on Clavien-Dindo scale;	Minimum score 0; Maximum score 100. Higher score indicates worse complications	Day 30
Quality of Recovery QoR-15 measuring quality of recovery on Day 1 only	Minimum score 0; Maximum score 150. Higherscore indicates better recovery.	Day 1

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology

Publications and helpful links

General Publications

• Buggy DJ, Nolan R, Coburn M, Columb M, Hermanides J, Hollman MW, Zarbock A. Protocol for a prospective, international cohort study on the Management and Outcomes of Perioperative Care among European Diabetic Patients (MOPED). BMJ Open. 2021 Sep 6;11(9):e044394. doi: 10.1136/bmjopen-2020-044394.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 10, 2020
• First Posted (Actual): August 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Diabetes Mellitus; Postoperative complications
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Postoperative Complications
• Other Study ID Numbers: MOPED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No