FLO-ELA is the FLuid Optimisation in Emergency LAparotomy trial. It is a large pragmatic clinical trial which aims to find out whether cardiac-output guided haemodynamic therapy given to patients during and shortly after emergency bowel surgery could save lives, when compared with usual care. The trial is being run in 100 UK hospitals and will study nearly 8000 patients.
This project is funded by the National Institute for Health Research Health Technology Assessment programme (project number 15/80/54).
We aim to trial a treatment used to guide the dose and timing of fluid administered into the bloodstream to patients during and shortly after surgery. We will trial this treatment, called ?goal - directed haemodynamic therapy? (GDHT), in patients undergoing emergency bowel surgery (laparotomy).
Emergency laparotomy is a common major emergency surgical procedure, performed to treat life threatening conditions caused by cancer, infections or previous surgery. Over 30,000 people in England & Wales undergo this surgery annually at a cost of over £650m. Outcomes from emergency bowel surgery are poor; 14% of patients aged over 50 die within a month of surgery, rising to 20% within three months. As this surgery is so common, treatments that reduce death rates even slightly could save hundreds of lives.
Major surgery and critical illness (both features of emergency bowel surgery) reduce blood flow to vital organs. This can cause serious complications and death after surgery. Fluids are given into the bloodstream to improve blood flow. Giving the right amount of fluid at the right time has a major impact on outcomes after surgery, but is hard to gauge accurately. Clinicians normally use signs such as heart rate and blood pressure to guide them, but these can be unreliable.
GDHT aims to address this. It lets clinicians determine the dose and timing of fluid to give patients, guided by a monitor measuring the blood flow pumped by the heart. GDHT may be beneficial in planned surgery, but has not been properly tested in the complex setting of emergency bowel surgery.
Primary objective of the trial
To determine whether GDHT given to patients aged 50+ during and for up to six hours after emergency laparotomy reduces the number of deaths within 90 days of surgery.
Secondary objectives of the trial
To determine whether GDHT:
- reduces deaths within one year of surgery
- reduces time spent in intensive care and in hospital after surgery
- is good value for money
Trial of 7646 patients randomly assigned to GDHT or usual care in 100 hospitals over three years. This will tell us whether GDHT reduces mortality from 19% to 16% within 90 days of surgery. This would equate to >700 lives saved annually in the UK. The trial is designed to be efficient and economical by:
- using an ongoing database (National Emergency Laparotomy Audit) for all trial data; NO extra data collection from patients.
- reducing the need for research staff. Clinical staff will be responsible for trial procedures. They are familiar with GDHT and have shown support for the trial through surveys on research priorities and their views on this treatment. Front-line anaesthetic and surgical trainee doctors will recruit patients round the clock. Their research networks have a proven track record in trial recruitment and are partners in this proposal.
Patient and public involvement in designing and running the trial
We have had active patient involvement from the outset. A 2015 James Lind Alliance project ranked this topic in the ten most important research questions in perioperative medicine. We discussed this proposal in detail with a patient with personal experience of emergency laparotomy as well as a member of the Intensive Care Society Patients and Relatives Committee. The proposal has been reviewed by the Royal College of Anaesthetists Patient, Carer and Public Involvement and Engagement (RCoA PCPIE) in Research Group. This feedback has shaped the design of the proposed trial. For example, together we developed a recruitment and consent process felt to be effective and acceptable to participants and their carers. Our lay member, along with the PCPIE group, has helped develop our patient information, will attend trial meetings and be involved in key decisions throughout the trial. Ongoing public input and support from the RCoA PCPIE group will also help dissemination of the trial outcomes to a non-medical audience.
Disseminating the trial results
FLO-ELA will provide definitive evidence on the value of this treatment. The results will be widely disseminated to front-line NHS staff, patients and healthcare policy makers. The trial will be carried out in a ?real world? NHS setting so we expect widespread uptake of GDHT for this group if found to be beneficial.
Notification on information use for FLO-ELA participants
University Hospital Southampton NHS Foundation Trust is the sponsor for this study based in the United Kingdom/ England. We will be using information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. University Hospital Southampton NHS Foundation trust will keep identifiable information about you for 20 years after the study has finished.
Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information by contacting the trial Chief Investigator Dr Mark Edwards at admin(at)floela.org. (please replace the (at) with the @ symbol when sending email)