Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT04511312
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management and Outcomes of Perioperative Care Among European Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days at Home at 30 Days after surgery (DAH-30)', 'timeFrame': '30 days', 'description': 'Number of days at home in the 30 days post surgery'}], 'secondaryOutcomes': [{'measure': 'Comprehensive Complications Index (CCI) score, based on Clavien-Dindo scale;', 'timeFrame': 'Day 30', 'description': 'Minimum score 0; Maximum score 100. Higher score indicates worse complications'}, {'measure': 'Quality of Recovery QoR-15 measuring quality of recovery on Day 1 only', 'timeFrame': 'Day 1', 'description': 'Minimum score 0; Maximum score 150. Higherscore indicates better recovery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Surgery', 'Postoperative complications'], 'conditions': ['Diabetes Mellitus', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '34489264', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThere 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).\n\nFurther, 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.", 'detailedDescription': 'see brief summary'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General population', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Ambulatory, elective or emergency surgery and patients who receive postoperative care in intensive care or high dependency units will be included.\n\nExclusion Criteria:\n\n* Patients who are not diabetic\n* Patients with gestational diabetes\n* Patients undergoing minor surgery'}, 'identificationModule': {'nctId': 'NCT04511312', 'briefTitle': 'Management and Outcomes of Perioperative Care Among European Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'European Society of Anaesthesiology'}, 'officialTitle': 'Management and Outcomes of Perioperative Care Among European Diabetic Patients: (MOPED): A Prospective Observational, International Cohort Study', 'orgStudyIdInfo': {'id': 'MOPED'}}, 'contactsLocationsModule': {'locations': [{'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'ESAIC', 'role': 'CONTACT'}], 'facility': 'Mater University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'saman Homayun Sepehr, Master', 'role': 'CONTACT', 'email': 'saman.sepehr@esahq.org', 'phone': '3222273999'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Society of Anaesthesiology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}