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NCT Number: NCT06738004

National Emergency Bariatric Surgery Audit

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Luton and Dunstable Hospital

Luton, United Kingdom

Location status: Recruiting

Location contact

Alan Askari

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30-day mortality

    Time frame: up to 30 days from procedure or admission

    Time in days

  2. Inpatient length of stay

    Time frame: Up to 100 weeks from admission

    Time in days

  3. Clavien-Dindo Classification of Complications

    Time frame: through study completion, an average of 1 year

    Severity of complication

Secondary outcomes

  1. Frequency and rate of nutritional support

    Time frame: through study completion, an average of 1 year

    Rate of enteral, or parenteral nutritional support

  2. Frequency and type of interventional radiology

    Time frame: through study completion, an average of 1 year

    Need for drains or other radiological procedures

  3. Frequency and type of surgery, diagnostic or therapeutic procedures

    Time frame: 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

  4. Frequency of admission to critical care units

    Time frame: through study completion, an average of 1 year

    Identify need for critical care

  5. Engagement with NHS specialised weight management services

    Time frame: through study completion, an average of 10 years prior to admission

    Identify engagement with NHS services for bariatric surgery

  6. Site and time of index bariatric surgery

    Time frame: Time from index surgery to admission

    Whether patient had surgery at the admitting hospital, other site in the UK or abroad

Study contacts

Contact information is provided by the study sponsor or research team.

Alan Askari, FRCS

CONTACT

[email protected]

Mohamed Aly, FRCS

CONTACT

[email protected]

01895 279994

Sponsors and collaborators

Lead sponsor

Bedfordshire Hospitals NHS Foundation Trust

Other

Collaborators

  • Alan Askari
  • Aruna Munasinghe
  • Dimitri Pournaras
  • Fahad Iqbal
  • Marianne Hollyman
  • Matthew Lee
  • Omer Al-taan
  • Roxanna Zakeri

Registry information

Official study title

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

Acronym: NEBSA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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