Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT03772392
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2018-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time of functional recovery from surgery', 'timeFrame': '90 days', 'description': 'Time to achieve discharge criteria post-operatively'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '90 days', 'description': 'Post operative complications'}, {'measure': 'Compliance', 'timeFrame': '90 days', 'description': 'Adherence rates to ERAS protocol and individual ERAS components'}, {'measure': 'Length of Stay', 'timeFrame': '90 days', 'description': 'Time in hospital after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Diseases', 'Pancreas Disease']}, 'descriptionModule': {'briefSummary': 'ERAS protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.\n\nERAS protocols within HPB units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.\n\nIn the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.', 'detailedDescription': '1.1 Background\n\nEnhanced Recovery After Surgery(ERAS) protocols have been utilized extensively in abdominal and non abdominal surgery over the past 20 years. These protocols incorporate evidence based, multi-disciplinary peri-operative care components. Compliance with these protocols is associated with reduced length of stay, reduced morbidity and reduced hospital costs.\n\nERAS protocols within hepatobiliary pancreatic (HPB) units are les well established with less evidence supporting their use. Liver resection protocols are increasing in use, but ERAS post Whipples resection is less established.\n\n1.2 RATIONALE FOR STUDY\n\nIn the HPB unit at the Royal Infirmary of Edinburgh, the liver HPB protocol is in use but a recent audit identified that that the compliance rate is low with compliance rates as low as 30 per cent in some care domains.\n\n2\\. OBJECTIVES\n\nTo compare the compliance of ERAS protocol care components within an HPB unit before and after an education programme.\n\n3\\. STUDY POPULATION\n\n3.1 NUMBER OF PARTICIPANTS An attempt to observe 100 patients will be made over the study period. A preliminary audit of 27 patients has been performed.\n\n4\\. PARICIPANT SELECTION\n\n4.1 IDENTIFYING PARTICIPANTS\n\nThose patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.\n\n4.2 CONSENT The ERAS protocol is part of the unit policy and so patients will not be undergoing any intervention that is not already part of normal practice and consent. Therefore further or additional consent will not be required.\n\n5\\. DATA COLLECTION Over a six month period the compliance to the ERAS protocol will be assessed in patients undergoing HPB resections.\n\nCompliance programme\n\n1. Patients will be given an information leaflet describing their post-operative care pathway\n2. Nursing and medical staff will receive education regarding the ERAS protocol and achievements\n3. Auditing of the ERAS protocol adherence will subsequently be performed\n\nOutcome measures\n\n1. Functional recovery\n2. Morbidity\n3. Compliance rate of the individual peri-operative care components\n4. Drop out rate\n5. Length of stay\n6. STATISTICAL ANALYSIS Chi squared analysis of dichotomised data will be performed. T test and Mann Whitney U tests will be performed to assess differences between the pre and post education programme results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those patients to be included will be identified from the theatre schedule as listed for HPB resectional surgery. Their compliance with the ERAS protocol will then be observed over the course of their stay.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients undergoing open HPB resectional surgery within the HPB unit at the Royal Infirmary of Edinburgh\n\nExclusion Criteria:\n\n* Laparoscopic surgery Non resectional surgery'}, 'identificationModule': {'nctId': 'NCT03772392', 'briefTitle': 'Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Enhanced Recovery After Surgery for Hepatobiliary-Pancreatic Surgery', 'orgStudyIdInfo': {'id': '18185'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HPB resection', 'type': 'PROCEDURE', 'description': ':Liver and Pancreas surgery - Compliance with ERAS protocol'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'NHS Lothian', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}