EPOCH Trial
Research type
Research Study
Full title
Enhanced Peri-Operative Care for High-risk patients (EPOCH) Trial: A stepped wedge randomised cluster trial of a quality improvement intervention for patients undergoing emergency laparotomy
IRAS ID
135585
Contact name
Rupert Pearse
Contact email
Sponsor organisation
Queen Mary's University London
Research summary
The EPOCH trial is a quality improvement project to implement an integrated care pathway in patients scheduled for emergency laparotomy (surgery in the abdominal area). The intervention is a combination of the care pathway and the quality improvement project. More than 150,000 high-risk patients undergo emergency surgery each year in the NHS and round 35,000 patients undergo a procedure known as ‘emergency laparotomy’. Around 180 patients undergo emergency laparotomy in a typical NHS hospital each year, with a 90-day mortality of 25%.
The integrated care pathway has a number of different components which include early diagnostic tests (CT scan), consultant-led decision making and treatment, advanced haemodynamic monitoring (e.g. blood pressure & heart function) and critical care admission. All of these components are currently available, none are new, but there is variability in their use across hospitals. The intervention is designed to increase compliance with these components of the care pathway. The aim is to confirm the effect of this intervention on survival at 90-days after surgery.
All patients aged 40 yrs and over undergoing non-elective open abdominal surgery in participating hospitals will be eligible for inclusion in the trial. The trial will exclude simple appendicectomy, gynaecological laparotomy, surgery related to organ transplant, laparotomy for traumatic injury and laparotomy to treat complications of recent surgery. At least ninety NHS hospitals across the UK will take part and be organised into fifteen groups or ‘clusters’ of six hospitals. Every five weeks one cluster will be allocated at random to start the trial intervention. All participating hospitals will be exposed to the intervention by the end of the trial period which will run for 85 weeks.
A health economics evaluation will be undertaken, six of the hospitals will also invite patients to participate in a study exploring their quality of life following an emergency laparotomy.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0415
Date of REC Opinion
29 Nov 2013
REC opinion
Further Information Favourable Opinion