Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 12:23 PM
Study NCT ID:
NCT04696367
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2019-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nutritional Deficit in Emergency Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007813', 'term': 'Laparotomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-07', 'studyFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2021-01-05', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time without nutrition (measured in days)', 'timeFrame': 'within 90 days of admission to hospital', 'description': 'This is defined as the time elapsed between last normal enteral intake, and resumption of enteral intake, or naso-enteric feeding, or parenteral nutrition.'}], 'secondaryOutcomes': [{'measure': 'In hospital complications', 'timeFrame': 'within 90 days of admission to hospital', 'description': 'Complications related to surgery measured using the comprehensive complication index'}, {'measure': 'Feasibility of completion of complications at day of discharge', 'timeFrame': 'within 90 days of admission to hospital', 'description': 'Proportion of patients with a completed comprehensive complication index'}, {'measure': 'Change in health utility', 'timeFrame': 'Measurements take at baseline, 5 days post-operatively and 90 days post-operatively', 'description': 'Measured using EQ-5D-5L (EuroQol- five dimension - five level)'}, {'measure': 'Feasibility of completion of EQ-5D-5L (EuroQol- five dimension - five level) at 90 days', 'timeFrame': '90 days post operatively', 'description': 'Reported as proportion of respondents replying'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emergency surgery', 'malnutrition', 'pilot study'], 'conditions': ['Emergencies', 'Surgery', 'Malnutrition']}, 'descriptionModule': {'briefSummary': "Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.", 'detailedDescription': "Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending two UK hospitals which provide emergency surgery services who require an emergency laparotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to consent,\n\n -≥ 18 years old\n* eligible for inclusion in National Emergency Laparotomy Audit\n* first procedure during admission (\\<7 days from admission).\n\nExclusion Criteria:\n\n* Recent discharge from hospital (within 60 days),\n* unable to provide informed consent\n* life expectancy \\<12 months\n* prisoners\n* lack mental capacity\n* language barrier affecting ability to provide consent'}, 'identificationModule': {'nctId': 'NCT04696367', 'acronym': 'INDIcatES', 'briefTitle': 'Impact of Nutritional Deficit in Emergency Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sheffield Teaching Hospitals NHS Foundation Trust'}, 'officialTitle': 'Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study', 'orgStudyIdInfo': {'id': 'STH20936'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with acute intra-abdominal pathology', 'description': 'Patients admitted to hospital with acute intra-abdominal pathology', 'interventionNames': ['Procedure: Emergency laparotomy']}], 'interventions': [{'name': 'Emergency laparotomy', 'type': 'PROCEDURE', 'otherNames': ['Celiotomy'], 'description': 'Midline laparotomy for acute intra-abdominal pathology', 'armGroupLabels': ['Patients with acute intra-abdominal pathology']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DN2 5LT', 'city': 'Doncaster', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Doncaster Royal Infirmary', 'geoPoint': {'lat': 53.52285, 'lon': -1.13116}}, {'zip': 'S5 7AU', 'city': 'Sheffield', 'state': 'South Yorkshire', 'country': 'United Kingdom', 'facility': 'Sheffield Teaching Hospitals', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': "Timothy O'Connor, MBChB", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheffield Teaching Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheffield Teaching Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}