Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT06738004
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Emergency Bariatric Surgery Audit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2024-12-12', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality', 'timeFrame': 'up to 30 days from procedure or admission', 'description': 'Time in days'}, {'measure': 'Inpatient length of stay', 'timeFrame': 'Up to 100 weeks from admission', 'description': 'Time in days'}, {'measure': 'Clavien-Dindo Classification of Complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Severity of complication'}], 'secondaryOutcomes': [{'measure': 'Frequency and rate of nutritional support', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Rate of enteral, or parenteral nutritional support'}, {'measure': 'Frequency and type of interventional radiology', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Need for drains or other radiological procedures'}, {'measure': 'Frequency and type of surgery, diagnostic or therapeutic procedures', 'timeFrame': 'through study completion, an average of 15 years post-op from index surgery', 'description': 'Description of the type of procedure or intervention required to treat or diagnose complications following bariatric surgery'}, {'measure': 'Frequency of admission to critical care units', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Identify need for critical care'}, {'measure': 'Engagement with NHS specialised weight management services', 'timeFrame': 'through study completion, an average of 10 years prior to admission', 'description': 'Identify engagement with NHS services for bariatric surgery'}, {'measure': 'Site and time of index bariatric surgery', 'timeFrame': 'Time from index surgery to admission', 'description': 'Whether patient had surgery at the admitting hospital, other site in the UK or abroad'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Emergency complications', 'National audit', 'Surgical outcomes', 'Management strategies', 'United Kingdom', 'Patient safety', 'Quality improvement', 'Morbidity and mortality', 'Postoperative complications'], 'conditions': ['Bariatric Surgery', 'Postoperative Complications', 'Emergencies', 'Surgical Procedures, Operative', 'Outcome Assessment (Health Care)', 'Quality Improvement', 'Morbidity', 'Mortality']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the incidence, management, and outcomes of complications following bariatric surgery in patients in the United Kingdom. The main questions it aims to answer are:\n\n* What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK?\n* What are the current practices for managing these complications, and how do they impact patient outcomes?\n\nParticipants will:\n\nBe identified from hospitals treating patients presenting with complications following bariatric surgery.\n\nHave their data collected regarding demographics, surgical history, complications, treatments, and outcomes.\n\nResearchers will compare different management strategies and their impact on patient outcomes, with the aim of identifying best practices to improve emergency bariatric care and factors leading to patients attending as an emergency.', 'detailedDescription': 'The National Emergency Bariatric Surgery Audit (NEBSA) is an observational study aimed at investigating the incidence, management, and outcomes of complications following bariatric surgery in the United Kingdom. The detailed description of the protocol includes the following components:\n\nPatient Recruitment and Data Collection:\n\nPatients will be identified in hospitals across the UK where they present for an unplanned intervention to treat a complication related to or following bariatric surgery.\n\nData on demographics, surgical history, site and type of index bariatric surgery, comorbidities, complications, treatments, and outcomes will be collected through a combination of electronic health records and manual data extraction.\n\nQuality Assurance Plan:\n\nData checks will be performed to ensure range, completeness and consistency with other data fields in the registry.\n\nData entry is restricted in most fields of the data form to ensure conformity of the entries and facilitate analysis.\n\nSample Size Assessment:\n\nThis is a prospective observational study, so a sample size assessment is not required. Data collection will continue for a six month period per centre then analysed to report any statistically significant findings.\n\nPlan for Missing Data:\n\nMissing data is reported back to the collaborating sites to complete.\n\nStatistical Analysis Plan:\n\nThe Shapiro-Wilk test will be used to check variables for Gaussian distribution. Basic demographics will be presented as absolute numbers of participants with the respective percentage per group or as parameter mean and standard deviation or median and range, depending on distribution. For comparisons of interval-scaled variables, unpaired t tests will be performed. Nonparametric between-group testing will be undertaken with 2-tailed Mann-Whitney U tests. Additionally, the chi-square test or Fisher exact test will be applied to nominal scale data. Multivariable linear regression be performed for differences among baseline demographics. Analyses will be performed in RStudio with significance defined with p \\< 0.05.\n\nThe NEBSA will provide valuable insights into the prevalence, management, and outcomes of complications following bariatric surgery in the UK. By comparing different management strategies and their impact on patient outcomes, this study aims to identify best practices for emergency bariatric care, ultimately improving patient outcomes and overall healthcare quality. Another important aim is analysing the effect of patient demographics, and engagement with NHS specialised weight loss services on the choice of route for bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients admitted from these locations i) the emergency department, clinic, urgent care or primary care to the bariatric surgical team as an emergency; ii) from an inpatient team as an urgent referral; iii) a return to theatre following an elective bariatric procedure; iv) another hospital via patient transfer to a specialised unit,with the intent to treat or diagnose complications of bariatric surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admissions from i) the emergency department, clinic, urgent care or primary care to the bariatric surgical team as an emergency; ii) from an inpatient team as an urgent referral; iii) a return to theatre following an elective bariatric procedure; iv) another hospital via patient transfer to a specialised unit.\n* Participants undergoing any intervention or procedure to treat or diagnose bariatric complications, (e.g., OGDs, interventional radiology, surgery, supplemental enteral or parenteral nutrition).\n\nExclusion Criteria:\n\n* age \\<18 years old\n* have a length of stay \\<24 hrs.\n* initial diagnosis of BSE is changed or if their readmission is found to be unrelated to previous bariatric surgery.'}, 'identificationModule': {'nctId': 'NCT06738004', 'acronym': 'NEBSA', 'briefTitle': 'National Emergency Bariatric Surgery Audit', 'organization': {'class': 'OTHER', 'fullName': 'Bedfordshire Hospitals NHS Foundation Trust'}, 'officialTitle': 'A National Multi-centre Prospective Audit of Unplanned Surgical and Endoscopic Interventions in Patients Who Have Undergone Bariatric Surgery in the UK or Abroad', 'orgStudyIdInfo': {'id': 'NEBSA1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Luton', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alan Askari', 'role': 'CONTACT', 'email': 'alan.askari@nhs.net'}], 'facility': 'Luton and Dunstable Hospital', 'geoPoint': {'lat': 51.87967, 'lon': -0.41748}}], 'centralContacts': [{'name': 'Mohamed Aly, FRCS', 'role': 'CONTACT', 'email': 'm.aly@nhs.net', 'phone': '01895 279994'}, {'name': 'Alan Askari, FRCS', 'role': 'CONTACT', 'email': 'alan.askari@nhs.net'}], 'overallOfficials': [{'name': 'Mohamed Aly, FRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hillingdon Hospitals NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bedfordshire Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alan Askari', 'class': 'UNKNOWN'}, {'name': 'Aruna Munasinghe', 'class': 'UNKNOWN'}, {'name': 'Omer Al-taan', 'class': 'UNKNOWN'}, {'name': 'Fahad Iqbal', 'class': 'UNKNOWN'}, {'name': 'Dimitri Pournaras', 'class': 'UNKNOWN'}, {'name': 'Matthew Lee', 'class': 'UNKNOWN'}, {'name': 'Roxanna Zakeri', 'class': 'UNKNOWN'}, {'name': 'Marianne Hollyman', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Upper GI and General Surgeon', 'investigatorFullName': 'Mohamed Aly', 'investigatorAffiliation': 'Bedfordshire Hospitals NHS Foundation Trust'}}}}