The Best Care for Abdominal Emergencies Study

Peritonitis Clinical Trial

— BCAE  

Official title:

The BCAE Study: Best Care for Abdominal Emergencies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04577339
• Other study ID #: PHT/2019/72
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: September 2020
• Source: Portsmouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2500
• Est. completion date: March 30, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Bowel Obstruction
• Bowel Perforated
• Bowel; Ischemic, Acute
• Emergencies
• Intestinal Obstruction
• Peritonitis

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals University NHS Trust	Portsmouth	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Simon Toh	University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rates of different interventions	Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.	2013-2020
Secondary	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
Secondary	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.	2013-2020

External Links

•   The BCAE Study website