A medical trial looking at ways to improve the quality and delivery of care for patients having emergency abdominal surgery

Not Applicable

Completed

• Conditions: Emergency Laparotomy; Surgery

• Registration Number: ISRCTN80682973
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30424818 results (added 23/04/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31030986 results (added 30/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-07
• Study Completion: 2017-04-30
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16000

Inclusion Criteria

Patients - All patients aged 40 years and over undergoing non-elective open abdominal surgery in participating hospitals during an 85 week period will be eligible for inclusion in the data analysis. The patient inclusion criteria are identical to those of the Healthcare Quality Improvement Partnership National Emergency Laparotomy Audit (HQIP-NELA) and the core EPOCH dataset will only include patient level data gathered by the audit. Hospital sites and clusters - Participating hospitals must undertake a significant volume of emergency laparotomies, participate in the National Emergency Laparotomy Audit, nominate specialty leads from surgery, anaesthesia and critical care, and secure the support from their NHS Trust Board to participate in the EPOCH study. Hospitals which already use an integrated care pathway to maintain standards of care for this patient group will be excluded. Clusters will be organised geographically with specific attention to the rotation of clinical staff and patient referral patterns between hospitals to minimise contamination of pre-intervention hospitals.

Exclusion Criteria

The following patients will be excluded:
1. Simple appendicectomy
2. Gynaecological laparotomy
3. Surgery related to organ transplant
4. Laparotomy for traumatic injury
5. Laparotomy to treat complications of recent elective surgery
6. Patients whose data has previously been included in the EPOCH trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality at 90 days following surgery

Secondary Outcome Measures

Name	Time	Method
<br> 1. All cause mortality at 180 days following surgery<br> 2. Duration of hospital stay<br> 3. Hospital re-admission within 180 days of surgery<br> In six hospitals we will collect EQ-5D 3L and healthcare resource use data preoperatively, and at 90 and 180 days post surgery to perform a health economics analysis.<br>