Bariatric SurgeryNEBSANCT06738004
National Emergency Bariatric Surgery Audit
An observational study of Bariatric Surgery and Postoperative Complications, run by Bedfordshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgery, Postoperative Complications, Emergencies
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2023to 9 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alan Askari, FRCS contact
United Kingdom1 site, 1 recruiting
- Recruiting
Luton and Dunstable Hospital
Luton
Alan Askari, alan.askari@nhs.net
About this study
Official 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
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?
Read more
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.
Read the 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.
- Conditions
- Bariatric Surgery, Postoperative Complications, Emergencies, Surgical Procedures, Operative, Outcome Assessment (Health Care), Quality Improvement
- Keywords
- Bariatric surgery, Emergency complications, National audit, Surgical outcomes, Management strategies, United Kingdom, Patient safety, Quality improvement, Morbidity and mortality, Postoperative complications
- Medical subject headings
- Postoperative Complications, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Time in days
Measured: up to 30 days from procedure or admission
Inpatient length of stay
Time in days
Measured: Up to 100 weeks from admission
Clavien-Dindo Classification of Complications
Severity of complication
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Frequency and rate of nutritional support
Rate of enteral, or parenteral nutritional support
Measured: through study completion, an average of 1 year
Frequency and type of interventional radiology
Need for drains or other radiological procedures
Measured: 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
Measured: 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
Measured: through study completion, an average of 1 year
Engagement with NHS specialised weight management services
Identify engagement with NHS services for bariatric surgery
Measured: 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
Measured: Time from index surgery to admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start9 Nov 2023
- Primary completion9 Dec 2025 (estimated)
- Study completion9 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bedfordshire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Alan Askari, Aruna Munasinghe, Omer Al-taan, Fahad Iqbal, Dimitri Pournaras, Matthew Lee, Roxanna Zakeri, Marianne Hollyman
- Responsible party
- Principal investigator, Mohamed Aly, Bedfordshire Hospitals NHS Foundation Trust
- Investigators
- Mohamed Aly, FRCS, Principal investigator, The Hillingdon Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738004
- Sponsor's protocol ID
- NEBSA1
- Acronym
- NEBSA
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06738004
- Acronym / sponsor ID
- NEBSA / NEBSA1
- Conditions
- Bariatric Surgery, Postoperative Complications, Emergencies, Surgical Procedures, Operative, Outcome Assessment (Health Care), Quality Improvement
- Keywords
- Bariatric surgery, Emergency complications, National audit, Surgical outcomes, Management strategies, United Kingdom, Patient safety, Quality improvement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bedfordshire Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Alan Askari, Aruna Munasinghe, Omer Al-taan, Fahad Iqbal, Dimitri Pournaras, Matthew Lee, Roxanna Zakeri, Marianne Hollyman
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 9 Dec 2025 (estimated)
- Study completion
- 9 Dec 2025 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day mortality
Time frame: up to 30 days from procedure or admission
Time in days
Inpatient length of stay
Time frame: Up to 100 weeks from admission
Time in days
Clavien-Dindo Classification of Complications
Time frame: through study completion, an average of 1 year
Severity of complication
6 secondary outcomes
Frequency and rate of nutritional support
Time frame: through study completion, an average of 1 year
Frequency and type of interventional radiology
Time frame: through study completion, an average of 1 year
Frequency and type of surgery, diagnostic or therapeutic procedures
Time frame: through study completion, an average of 15 years post-op from index surgery
Frequency of admission to critical care units
Time frame: through study completion, an average of 1 year
Engagement with NHS specialised weight management services
Time frame: through study completion, an average of 10 years prior to admission
Site and time of index bariatric surgery
Time frame: Time from index surgery to admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alan Askari, FRCS contact
Mohamed Aly, FRCS principal investigator
The Hillingdon Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Postoperative Complications, run by Bedfordshire Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Aly, FRCS (01895 279994, m.aly@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: up to 30 days from procedure or admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.