National Emergency Bariatric Surgery Audit (NEBSA)

A National Multi-centre Prospective Audit of Unplanned Surgical and Endoscopic Interventions in Patients Who Have Undergone Bariatric Surgery in the UK or Abroad

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Mohamed Aly, FRCS; Phone Number: 01895 279994; Email: m.aly@nhs.net
• Study Contact Backup: Name: Alan Askari, FRCS; Email: alan.askari@nhs.net

Study Locations

• United Kingdom
  • Luton, United Kingdom
    • Recruiting
    • Luton and Dunstable Hospital
    • Contact: Alan Askari; Email: alan.askari@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and rate of nutritional support	Rate of enteral, or parenteral nutritional support	through study completion, an average of 1 year
Frequency and type of interventional radiology	Need for drains or other radiological procedures	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	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	through study completion, an average of 1 year
Engagement with NHS specialised weight management services	Identify engagement with NHS services for bariatric surgery	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 from index surgery to admission

Collaborators and Investigators

• Sponsor: Bedfordshire Hospitals NHS Foundation Trust
• Collaborators: Alan Askari; Aruna Munasinghe; Omer Al-taan; Fahad Iqbal; Dimitri Pournaras; Matthew Lee; Roxanna Zakeri; Marianne Hollyman
• Investigators: Principal Investigator: Mohamed Aly, FRCS, The Hillingdon Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Estimated): December 9, 2025
• Study Completion (Estimated): December 9, 2025

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative complications; Bariatric surgery; Patient safety; Quality improvement; Surgical outcomes; United Kingdom; Management strategies; Emergency complications; National audit; Morbidity and mortality
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies; Postoperative Complications
• Other Study ID Numbers: NEBSA1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No