Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-01 @ 10:30 PM
Study NCT ID:
NCT06334068
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2024-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SHOrt-term Glycemic Control for Reducing Post-SURGical Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessors, who will call patients or relatives 30 days after surgery, will be masked for the allocated group.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients in the preoperative anesthesia clinic are divided into one of the following groups:\n\n1. Short-term glycemic control group:\n\n Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.\n2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-06', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to resumption of normal diabetes therapy', 'timeFrame': '60 days after surgery', 'description': 'number in days'}, {'measure': 'Incidence of diabetic ketoacidosis or hypoglycemia', 'timeFrame': 'during the hospitalization period (within 30 days after surgery)', 'description': 'incidence (yes/no) outcome'}, {'measure': 'Incidence of use of intravenous insulin infusion therapy', 'timeFrame': 'during the hospitalization period (within 30 days after surgery)', 'description': 'incidence (yes/no) outcome'}, {'measure': 'Duration of use of intravenous insulin infusion therapy', 'timeFrame': 'during the hospitalization period (within 30 days after surgery)', 'description': 'duration in days and hours'}, {'measure': 'Change in diabetic management at 30 days', 'timeFrame': 'during the hospitalization period (after 30 days after surgery)', 'description': 'incidence (yes/no) outcome'}], 'primaryOutcomes': [{'measure': 'Number of days at home after surgery (DAH-30).', 'timeFrame': '30 days after surgery', 'description': 'Continuous outcome as the number of days over the 30 days after surgery.'}], 'secondaryOutcomes': [{'measure': 'Loss of follow-up after surgery', 'timeFrame': '30 days after Surgery', 'description': 'Incidence (yes/no) outcome'}, {'measure': 'Loss of follow up after the clinic preoperative assessment', 'timeFrame': '30 days after initial assessment', 'description': 'incidence (yes/no) outcome'}, {'measure': '30-day mortality', 'timeFrame': '30 days after surgery', 'description': 'incidence (yes/no) outcome'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days after surgery', 'description': 'continuous outcome: number of days untill discharge from hospital after surgery'}, {'measure': 'incidence of postoperative complications', 'timeFrame': '30 days after surgery', 'description': 'according to the comprehensive complications index (Kalt et al., 2023)'}, {'measure': 'Quality of Recovery15 (QoR-15)', 'timeFrame': 'after 24 hours of surgery', 'description': 'a score of 15 items'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes', 'Uncontrolled Diabtetes']}, 'descriptionModule': {'briefSummary': 'Perioperative dysglycemia-hyperglycemia, hypoglycemia, and glycemic variability-is associated with an increased risk for adverse outcomes. Several studies have reported the association between elevated preoperative HbA1c and postoperative complications.\n\nThere are no studies that confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries.\n\nConsequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality.', 'detailedDescription': 'Despite the limitations of measurements of HbA1c, guidelines for perioperative glycemic management suggest delaying elective surgery if HbA1c exceeds certain levels (7-8.5%) (Joshi et al., 2010; CPOC, 2022). However, no studies confirm that postponing elective surgery improves patient outcomes. Likewise, no prospective trials have studied whether short-term glycemic control reduces postoperative complications and unnecessary patient delays in elective surgeries (Duggan et al., 2017).\n\nConsequently, this randomized controlled trial aimed to investigate the effects of short-term glycemic control before major abdominal surgery on postoperative morbidity and mortality. The study hypothesis is that in diabetic patients who are presenting for non-cardiac non-elective surgery and whose HbA1c is ≥7.5% (≥58 mmol/mol), short-term glycemic control would improve outcome compared to standard-of-care, as measured with days-at-home at 30 postoperative days (DAH-30).\n\nThe current study aims to detect the value of short-term glycemic control in uncontrolled diabetic patients (preoperative HbA1c ≥7.5% \\[≥58 mmol/mol\\]) for reducing postoperative morbidity and mortality.\n\nThe patients in the preoperative anesthesia clinic will be randomized into one of the upcoming groups:\n\n1. Short-term glycemic control group:\n\n Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140 - 180 mg/dl) using basal-bolus insulin protocol plus correctional doses as needed.\n2. Standard-of-care group: Patients will be admitted the day before surgery with the usual patient treatment.\n\nIn both groups, diabetic drugs will be managed per local protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult diabetic patients (≥18 years) of either sex scheduled for major abdominal surgery (estimated operative time is \\> 2 hours) with Hb A1c ≥7.5% (58 mmol/mol).\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Emergency Surgery\n* Elective surgery that can be postponed safely till glycemic control\n* Hb A1c \\< 7.5%\n* Pregnant patients\n* Patient Refusal'}, 'identificationModule': {'nctId': 'NCT06334068', 'acronym': 'Surg-ShoGR', 'briefTitle': 'SHOrt-term Glycemic Control for Reducing Post-SURGical Complications', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Short-term Glycemic Control in Patients With Uncontrolled Diabetes Mellitus Before Major Abdominal Surgery for Reducing Morbidity and Mortality: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS.24.03.2725'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Short-term glycemic control group', 'description': 'Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed.', 'interventionNames': ['Other: Short-term glycemic control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-of-care group', 'description': 'Patients will be admitted the day before surgery with the usual patient treatment.', 'interventionNames': ['Other: Standard-of-care group']}], 'interventions': [{'name': 'Short-term glycemic control group', 'type': 'OTHER', 'otherNames': ['Active Intervention'], 'description': 'Patients will be admitted to the hospital for 2-3 days before surgery. During this pilot study, patients will be admitted to the intermediate care unit to monitor and control preoperative blood glucose. We aim to maintain moderate glucose control (140-180 mg/dl) using the basal-bolus insulin protocol, plus correctional doses as needed.', 'armGroupLabels': ['Short-term glycemic control group']}, {'name': 'Standard-of-care group', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Patients will be admitted the day before surgery with the usual patient treatment.', 'armGroupLabels': ['Standard-of-care group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Aldakahlia', 'country': 'Egypt', 'facility': 'Moataz Maher Emara', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Moataz M Emara, MD, EDAIC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Will be reported as soon as possible.', 'ipdSharing': 'YES', 'description': 'The anonymized individual data will be available with the principal investigator on reasonable request after IRB approval within two years of publication.', 'accessCriteria': 'Will be reported as soon as possible.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}