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| Name | Class |
|---|---|
| University of Portsmouth | OTHER |
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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.
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:
Exclusion criteria:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparotomy or laparoscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rates of different interventions | Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes. | 2013-2020 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2013-2020 |
| Predict the risk of death for each patient group |
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Inclusion Criteria:
All acute general surgical adult patients admitted between 2013 and 2020 with all of the conditions below:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Portsmouth Hospitals University NHS Trust | Portsmouth | Hampshire | PO6 3LY | United Kingdom |
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| Label | URL |
|---|---|
| The BCAE Study website | View source |
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Fully anonymised patient data will be shared with our research partners in the Faculty of Health Modelling, University of Portsmouth
December 1st 2021 and for up to 2 years
Only fully anonymised data will leave the study site in strict accordance with GDPR and DPA.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 24, 2020 | Sep 30, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| D007415 | Intestinal Obstruction |
| D007511 | Ischemia |
| D007416 | Intestinal Perforation |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
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|
|
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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D010532 | Peritoneal Diseases |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |