Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-11-09
2025-12-09
Brief Summary
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* What is the prevalence of unplanned interventions due to complications following bariatric surgery in the UK?
* What are the current practices for managing these complications, and how do they impact patient outcomes?
Participants will:
Be identified from hospitals treating patients presenting with complications following bariatric surgery.
Have their data collected regarding demographics, surgical history, complications, treatments, and outcomes.
Researchers 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.
Detailed Description
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Patient Recruitment and Data Collection:
Patients 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.
Data 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.
Quality Assurance Plan:
Data checks will be performed to ensure range, completeness and consistency with other data fields in the registry.
Data entry is restricted in most fields of the data form to ensure conformity of the entries and facilitate analysis.
Sample Size Assessment:
This 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.
Plan for Missing Data:
Missing data is reported back to the collaborating sites to complete.
Statistical Analysis Plan:
The 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.
The 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Participants undergoing any intervention or procedure to treat or diagnose bariatric complications, (e.g., OGDs, interventional radiology, surgery, supplemental enteral or parenteral nutrition).
Exclusion Criteria
* have a length of stay \<24 hrs.
* initial diagnosis of BSE is changed or if their readmission is found to be unrelated to previous bariatric surgery.
18 Years
ALL
No
Sponsors
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Alan Askari
UNKNOWN
Aruna Munasinghe
UNKNOWN
Omer Al-taan
UNKNOWN
Fahad Iqbal
UNKNOWN
Dimitri Pournaras
UNKNOWN
Matthew Lee
UNKNOWN
Roxanna Zakeri
UNKNOWN
Marianne Hollyman
UNKNOWN
Bedfordshire Hospitals NHS Foundation Trust
OTHER
Responsible Party
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Mohamed Aly
Consultant Upper GI and General Surgeon
Principal Investigators
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Mohamed Aly, FRCS
Role: PRINCIPAL_INVESTIGATOR
The Hillingdon Hospitals NHS Foundation Trust
Locations
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Luton and Dunstable Hospital
Luton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Alan Askari
Role: primary
Other Identifiers
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NEBSA1
Identifier Type: -
Identifier Source: org_study_id