National Emergency Bariatric Surgery Audit

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBedfordshire Hospitals NHS Foundation Trust

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

30-day mortality

Time in days

Time frame
up to 30 days from procedure or admission
2

Inpatient length of stay

Time in days

Time frame
Up to 100 weeks from admission
3

Clavien-Dindo Classification of Complications

Severity of complication

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Frequency and rate of nutritional support

Rate of enteral, or parenteral nutritional support

Time frame
through study completion, an average of 1 year
2

Frequency and type of interventional radiology

Need for drains or other radiological procedures

Time frame
through study completion, an average of 1 year
3

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

Time frame
through study completion, an average of 15 years post-op from index surgery
4

Frequency of admission to critical care units

Identify need for critical care

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bedfordshire Hospitals NHS Foundation Trust

Lead sponsor

Alan Askari

Collaborator

Aruna Munasinghe

Collaborator

Omer Al-taan

Collaborator

Fahad Iqbal

Collaborator

Dimitri Pournaras

Collaborator

Matthew Lee

Collaborator

Roxanna Zakeri

Collaborator

Marianne Hollyman

Collaborator