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National Emergency Bariatric Surgery Audit

Sponsor: Bedfordshire Hospitals NHS Foundation Trust

NCT ID: NCT06738004

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 25 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
500
Started
2023-11-09
Last checked
2024-12

Plain English Summary

What is this study?

  • • Testing a new treatment for bariatric surgery
  • • Clinical study - 500 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with bariatric surgery

Where?

  • • Luton - Luton and Dunstable Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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: * 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.

More detail

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.

Bariatric SurgeryPostoperative ComplicationsEmergenciesSurgical Procedures, OperativeOutcome Assessment (Health Care)Quality ImprovementMorbidityMortality

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Participants undergoing any intervention or procedure to treat or diagnose bariatric complications, (e.g., OGDs,...

Who cannot take part

  • ✗age \<18 years old
  • ✗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.
See the full criteria
Inclusion Criteria: * 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. * 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: * age \<18 years old * 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.

Where Is This Study? (1 UK site)

Luton and Dunstable Hospital

Luton, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Mohamed Aly, FRCS

Sponsor contact

CONTACT

01895 279994 m.aly@nhs.net

Alan Askari, FRCS

Sponsor contact

CONTACT

alan.askari@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2024-12