The Best Care for Abdominal Emergencies Study

NCT04577339 | Completed DMC

• 1 other identifier: PHT/2019/72
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Bowel Obstruction; Bowel; Ischemic, Acute; Bowel Perforated; Peritonitis; Acute Abdomen

Keywords

peritonitis; acute abdomen; laparotomy; laparoscopy; interventional radiology; risk assessment; care guidelines

Outcome Measures

Primary Outcomes (1)

• Mortality rates of different interventions

  Provide mortality rates for different treatment options, and analysis of short- and long-term outcomes.

  2013-2020

Secondary Outcomes (2)

• Define patient sub-groups with similar health characteristics

  2013-2020

• Predict the risk of death for each patient group

  2013-2020

Study Arms (1)

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

Interventions

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.

Also known as: Interventional radiology, Best supportive care

Adult patients with acute abdominal conditions

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• Maternity admissions during/after pregnancy
• Patients admitted or undergoing abdominal surgery for a second time or more

Sponsors & Collaborators

• University of Portsmouth: collaborator
• Portsmouth Hospitals NHS Trust: lead

Study Sites (1)

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Links

• The BCAE Study website

MeSH Terms

Conditions

Abdomen, Acute; Intestinal Obstruction; Ischemia; Intestinal Perforation; Peritonitis

Interventions

Laparotomy; Laparoscopy

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Intraabdominal Infections; Infections; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: January 8, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 26, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: December 1st 2021 and for up to 2 years
• Access Criteria: Only fully anonymised data will leave the study site in strict accordance with GDPR and DPA.

Locations

GB (1)