Management and Outcomes of Perioperative Care Among European Diabetic Patients

NCT04511312 | Recruiting

• 1 other identifier: MOPED
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Postoperative Complications

Keywords

Diabetes Mellitus; Surgery; Postoperative complications

Outcome Measures

Primary Outcomes (1)

• Days at Home at 30 Days after surgery (DAH-30)

  Number of days at home in the 30 days post surgery

  30 days

Secondary Outcomes (2)

• Comprehensive Complications Index (CCI) score, based on Clavien-Dindo scale;

  Day 30

• Quality of Recovery QoR-15 measuring quality of recovery on Day 1 only

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• European Society of Anaesthesiology: lead

Study Sites (1)

Mater University Hospital

Dublin, Ireland

RECRUITING

Related Publications (1)

• 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.

  PMID: 34489264 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Postoperative Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

saman Homayun Sepehr, Master

CONTACT

3222273999; saman.sepehr@esahq.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 13, 2020
• Study Start: May 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: August 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

IE (1)