National Emergency Bariatric Surgery Audit

Recruiting

• Conditions: Bariatric Surgery; Postoperative Complications; Emergencies; Surgical Procedures, Operative; Outcome Assessment (Health Care); Quality Improvement; Morbidity; Mortality

• Registration Number: NCT06738004
• Lead Sponsor: Bedfordshire Hospitals NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-09
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
30-day mortality	up to 30 days from procedure or admission	Time in days
Inpatient length of stay	Up to 100 weeks from admission	Time in days
Clavien-Dindo Classification of Complications	through study completion, an average of 1 year	Severity of complication

Secondary Outcome Measures

Name	Time	Method
Frequency and rate of nutritional support	through study completion, an average of 1 year	Rate of enteral, or parenteral nutritional support
Frequency and type of interventional radiology	through study completion, an average of 1 year	Need for drains or other radiological procedures
Frequency and type of surgery, diagnostic or therapeutic procedures	through study completion, an average of 15 years post-op from index surgery	Description of the type of procedure or intervention required to treat or diagnose complications following bariatric surgery
Frequency of admission to critical care units	through study completion, an average of 1 year	Identify need for critical care
Engagement with NHS specialised weight management services	through study completion, an average of 10 years prior to admission	Identify engagement with NHS services for bariatric surgery
Site and time of index bariatric surgery	Time from index surgery to admission	Whether patient had surgery at the admitting hospital, other site in the UK or abroad

Trial Locations

Locations (1)

Luton and Dunstable Hospital; 🇬🇧 Luton, United Kingdom