Clinical trial NCT04511312: Management and Outcomes of Perioperative Care Among European Diabetic Patients
Official title: Management and Outcomes of Perioperative Care Among European Diabetic Patients: (MOPED): A Prospective Observational, International Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Postoperative Complications
Keywords: Diabetes Mellitus
Surgery
Postoperative complications
Lead sponsor: European Society of Anaesthesiology
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

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.

Detailed description: see brief summary

Eligibility criteria: 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

Primary outcomes:
measure: Days at Home at 30 Days after surgery (DAH-30)
timeFrame: 30 days
Secondary outcomes:
measure: Comprehensive Complications Index (CCI) score, based on Clavien-Dindo scale;
timeFrame: Day 30
measure: Quality of Recovery QoR-15 measuring quality of recovery on Day 1 only
timeFrame: Day 1
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Mater University Hospital
Study officials:
References:
citation: 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.