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Acute AbdomenBCAENCT04577339

The Best Care for Abdominal Emergencies Study

An observational study of Acute Abdomen and Bowel Obstruction, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-centre retrospective cohort study utilising electronic hospital records. The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not. Read more about this study

Who is it for?
Ages 16 years and older
What is being tested?
Laparotomy or laparoscopy
Type of treatment
Surgery or procedure
How many people
2,500 participants
Where
1 siteUnited Kingdom
Study dates
8 Jan 2021to 1 May 2022
Phase
Observational
Are there results?
None posted in the registry

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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All acute general surgical adult patients admitted between 2013 and 2020 presenting with an acute abdomen due to an underlying acute intestinal condition to a single centre (an Acute NHS Hospital in UK).

Who may be able to join

  • All acute general surgical adult patients admitted between 2013 and 2020 with all of the conditions below:
  • Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
  • Must be >= 16 years of age at the time of admission
  • Have at least one full set of vital signs recorded on the day of admission
  • Have at least one full set of routine blood tests recorded on the day of admission

Who cannot join

  • Maternity admissions during/after pregnancy
  • Patients admitted or undergoing abdominal surgery for a second time or more

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Portsmouth Hospitals University NHS Trust

    Portsmouth, Hampshire, PO6 3LY

Other trials in United Kingdom

About this study

Official title: The BCAE Study: Best Care for Abdominal Emergencies

This is a single-centre retrospective cohort study utilising electronic hospital records.

The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not. Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020. The investigators will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. The investigators aim to identify 2 further groups where treatment is non-surgical (but could be medical or interventional radiology) or where treatment is considered futile, suggesting that an early focus on end of life care might be appropriate. The primary objective is to provide mortality rates for different treatment options, and analysis of short- and long-term outcomes. The secondary endpoints are to define patient sub-groups with similar health characteristics based on clinical data and an established risk index and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow the investigators to identify the best care pathways for each cluster.

Read the detailed description

Abdominal emergencies are common, involving perforation, obstruction or ischaemia of the bowel, often needing life-saving emergency surgery, with a large incision to access the abdominal cavity called "laparotomy". This procedure is high risk with 10% mortality rate. 30,000 emergency laparotomies are performed each year in England and Wales. Since 2013, the National Emergency Laparotomy Audit (NELA) has set standards of care and monitored outcomes for emergency laparotomy, which has reduced mortality from 11.8 to 9.5%. However, patients who do NOT have a laparotomy are not well characterised and do not receive the prioritised care patients having surgery do, even though their condition is no less severe. Initial research has shown a surprisingly large group of patients (32%) with an intestinal emergency do not have surgery and have 30-day mortality of 63%. There are three additional groups of patients admitted with abdominal emergencies: patients having keyhole surgery or interventional radiological procedures, and patients for whom any treatment would be futile and would benefit most from an end of life care pathway. Clearly further work is needed to investigate the management of ALL patients with intestinal emergency, to optimise care for each group of patients.The aim of this study is to improve care for all patients with an intestinal emergency, irrespective of whether they have surgery or not.

AIM:

This is a single-centre retrospective cohort study utilising electronic hospital records.

STUDY DESIGN:

Data will be derived from electronic patient records collected as part of routine clinical patient care on all general adult wards (excluding maternity) between 2013 and 2020.

Inclusion criteria:

  • Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes
  • Must be >= 16 years of age at the time of admission
  • Have at least one full set of vital signs recorded on the day of admission
  • Have at least one full set of routine blood tests recorded on the day of admission

Exclusion criteria:

  • Maternity admissions during/after pregnancy
  • Patients admitted or undergoing abdominal surgery for a second time or more Using OPCS-4 codes from PAS and TheatreManTM and NELA data, the investigators will then identify patients who had an emergency laparotomy, and those who had a laparoscopic procedure. We aim to identify a further group where treatment is futile, suggesting that an early focus on end of life care might be appropriate.

The investigators have estimated that we will have about 2,500 patients who fulfil the inclusion criteria in this period. Patient outcomes will be analysed from up to one year following their admission for acute abdomen.

PRIMARY OBJECTIVE:

To provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.

SECONDARY OBJECTIVE:

To define patient sub-groups with similar health characteristics based on clinical data and an established risk index, and to use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow us to identify the best care pathways for each cluster.

PRIMARY ENDPOINT:

The mortality risk for each treatment group

SECONDARY ENDPOINT:

The risk of other outcomes and long-term complications and association between patient factors and these outcomes

Being tested
Laparotomy or laparoscopy
Keywords
peritonitis, acute abdomen, laparotomy, laparoscopy, interventional radiology, risk assessment, care guidelines
Medical subject headings
Abdomen, Acute, Intestinal Obstruction, Ischemia, Intestinal Perforation, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparotomy or laparoscopyProcedure or surgery

    Also called Interventional radiology, Best supportive care

    Laparotomy is the opening of the abdominal cavity usually through a midline incision.

    Laparoscopy is using minimal access keyhole surgery to perform the surgery instead of laparotomy Interventional radiology is the use of imaging to perform a procedure on the abdomen without surgery, for example, using ultrasound to guide a needle to drain an abscess Best supportive care is usually end-of-life care concentration on relieving symptoms rather than treating the cause.

Study groups in NCT04577339
Study groupRoleWhat they receive
Adult patients with acute abdominal conditionsAll adult patients >=16years of age on all general adult wards (excluding maternity) between 2013 and 2020 with the following inclusion and exclusion criteria: Inclusion criteria: * Must have an acute intestinal condition, based on their ICD-10 codes and OPSC-4 codes * Must be >= 16 years of age at the time of admission * Have at least one full set of vital signs recorded on the day of admission * Have at least one full set of routine blood tests recorded on the day of admission Exclusion criteria: * Maternity admissions during/after pregnancy * Patients admitted or undergoing abdominal surgery for a second time or more
Receives: Procedure: Laparotomy or laparoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality rates of different interventions

    Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.

    Measured: 2013-2020

Secondary outcomes (2)
  1. Define patient sub-groups with similar health characteristics

    Define patient sub-groups with similar health characteristics based on clinical data and an established risk index.

    option, which will allow us to identify the best care pathways for each cluster.

    Measured: 2013-2020

  2. Predict the risk of death for each patient group

    Use statistical analysis to predict the risk of death for each patient group and treatment option, which will allow us to identify the best care pathways for each cluster.

    Measured: 2013-2020

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2020
  2. Study start8 Jan 2021
  3. Primary completion1 May 2022
  4. Study completion1 May 2022

Resources

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
Retrospective
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04577339
Sponsor's protocol ID
PHT/2019/72
Acronym
BCAE
Status last verified
Apr 2023
First submitted
30 Sep 2020
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Fully anonymised patient data will be shared with our research partners in the Faculty of Health Modelling, University of Portsmouth

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Abdomen and Bowel Obstruction, run by Portsmouth Hospitals NHS 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 26 Dec 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality rates of different interventions (time frame: 2013-2020). 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 26 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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