The Best Care for Abdominal Emergencies Study (BCAE)

December 18, 2025 updated by: Portsmouth Hospitals NHS Trust

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.

Study Overview

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

Study Type

Observational

Enrollment (Actual)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with acute abdominal conditions

All 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

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.

Other Names:
  • Interventional radiology
  • Best supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rates of different interventions
Time Frame: 2013-2020
Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.
2013-2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define patient sub-groups with similar health characteristics
Time Frame: 2013-2020

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.

2013-2020
Predict the risk of death for each patient group
Time Frame: 2013-2020
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.
2013-2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2021

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 6, 2020

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Fully anonymised patient data will be shared with our research partners in the Faculty of Health Modelling, University of Portsmouth

IPD Sharing Time Frame

December 1st 2021 and for up to 2 years

IPD Sharing Access Criteria

Only fully anonymised data will leave the study site in strict accordance with GDPR and DPA.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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