An observational study in Bariatric Surgery, Postoperative Complications and Emergencies, sponsored by Bedfordshire Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-17.
Sponsored by Bedfordshire Hospitals NHS Foundation Trust · Observational
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:
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.
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:
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.
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 500 is above the median of 353 across 714 observational studies indexed under Emergencies.
Browse Emergencies studies →This is the only study on the registry with Bedfordshire Hospitals NHS Foundation Trust as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
30-day mortality
Time in days
Time frame: up to 30 days from procedure or admission
Inpatient length of stay
Time in days
Time frame: Up to 100 weeks from admission
Clavien-Dindo Classification of Complications
Severity of complication
Time frame: through study completion, an average of 1 year
Frequency and rate of nutritional support
Rate of enteral, or parenteral nutritional support
Time frame: through study completion, an average of 1 year
Frequency and type of interventional radiology
Need for drains or other radiological procedures
Time frame: through study completion, an average of 1 year
Frequency and type of surgery, diagnostic or therapeutic procedures
Description of the type of procedure or intervention required to treat or diagnose complications following bariatric surgery
Time frame: through study completion, an average of 15 years post-op from index surgery
Frequency of admission to critical care units
Identify need for critical care
Time frame: through study completion, an average of 1 year
Engagement with NHS specialised weight management services
Identify engagement with NHS services for bariatric surgery
Time frame: through study completion, an average of 10 years prior to admission
Site and time of index bariatric surgery
Whether patient had surgery at the admitting hospital, other site in the UK or abroad
Time frame: Time from index surgery to admission
Plan to share: Undecided
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