BCAE: The Best Care for Abdominal Emergencies Study

Sponsor

Simon Toh (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04577339

Collaborator

University of Portsmouth (Other)

2,500

Enrollment

Location

15.9

Anticipated Duration (Months)

157.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Abdomen Bowel Obstruction Bowel; Ischemic, Acute Bowel Perforated Peritonitis	Procedure: Laparotomy or laparoscopy

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, 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

Study Design

Study Type:

Observational

Anticipated Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

The BCAE Study: Best Care for Abdominal Emergencies

Anticipated Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	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	Procedure: Laparotomy or laparoscopy 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

Arm

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

Procedure: Laparotomy or laparoscopy

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

Outcome Measures

Primary Outcome Measures

Mortality rates of different interventions [2013-2020]
Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.

Secondary Outcome Measures

Define patient sub-groups with similar health characteristics [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.
Predict the risk of death for each patient group [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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