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.
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
- Conditions the study is for
- Acute Abdomen, Bowel Obstruction, Bowel; Ischemic, Acute
- 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
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Laparotomy or laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
- First posted6 Oct 2020
- Study start8 Jan 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies 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
- Retrospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BCAE Study: Best Care for Abdominal Emergencies
- ClinicalTrials.gov ID
- NCT04577339
- Acronym / sponsor ID
- BCAE / PHT/2019/72
- Keywords
- peritonitis, acute abdomen, laparotomy, laparoscopy, interventional radiology, risk assessment, care guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 6 Oct 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with acute abdominal conditions | – | Procedure: Laparotomy or laparoscopyAll 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Maternity admissions during/after pregnancy
- Patients admitted or undergoing abdominal surgery for a second time or more
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparotomy or laparoscopyAlso: Interventional radiology, Best supportive careLaparotomy 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. | Procedure or surgery | Adult patients with acute abdominal conditions |
Primary outcome
Mortality rates of different interventions
Time frame: 2013-2020
Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.
2 secondary outcomes
Define patient sub-groups with similar health characteristics
Time frame: 2013-2020
Predict the risk of death for each patient group
Time frame: 2013-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- The BCAE Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Fully anonymised patient data will be shared with our research partners in the Faculty of Health Modelling, University of Portsmouth
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 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.