Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577339
Status:
UNKNOWN
Last Update Posted:
2020-10-06
First Post:
2020-09-30
Brief Title:
The Best Care for Abdominal Emergencies Study
Sponsor:
Simon Toh
Organization:
Portsmouth Hospitals NHS Trust
Study Overview
Official Title:
The BCAE Study Best Care for Abdominal Emergencies
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCAE
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
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
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 30000 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 118 to 95 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 patientsThe 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 duringafter 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 2500 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
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 duringafter 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 2500 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None