- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577339
The Best Care for Abdominal Emergencies Study (BCAE)
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
Status
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hampshire
-
Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Portsmouth Hospitals University NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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:
Exclusion criteria:
|
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:
|
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
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Pathologic Processes
- Signs and Symptoms, Digestive
- Intestinal Diseases
- Infections
- Digestive System Diseases
- Gastrointestinal Diseases
- Peritoneal Diseases
- Intraabdominal Infections
- Abdominal Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Ischemia
- Intestinal Obstruction
- Peritonitis
- Abdomen, Acute
- Intestinal Perforation
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Minimally Invasive Surgical Procedures
- Diagnostic Techniques, Surgical
- Endoscopy
- Laparoscopy
- Laparotomy
Other Study ID Numbers
- PHT/2019/72
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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