Peritonitis Clinical Trial
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. We will then identify patients who had an
emergency laparotomy, and those who had a laparoscopic procedure. We 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 us 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:
- 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, we 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.
We 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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