Patients & Public

FLO-ELA (FLuid Optimisation in Emergency LAparotomy) is a major clinical trial of a treatment given to patients during and shortly after emergency bowel surgery. It is funded by the National Institute for Health Research and will be recruiting patients between 2017 and 2022, with results released in 2024.

Research aims

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).

Background

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 increases the number of days spent alive and out of hospital within 90 days of randomisation.

Secondary objectives of the trial

To determine whether GDHT:

  • reduces deaths within 90 days and one year of surgery
  • reduces time spent in intensive care and in hospital after surgery
  • is good value for money

Trial design

Trial of 3138 patients randomly assigned to GDHT or usual care in up to 50 hospitals. This will tell us whether GDHT reduces deaths and increases the amount of time patients spend out of hospital within 90 days of surgery.

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 (UHSNHSFT) is the sponsor for this study based in the United Kingdom/ England. We will be using information, including personal data, from you, your medical records, and from NHS England, in order to undertake this study and to find out whether the new treatment we are trialling does improve outcomes after surgery. UHSNHSFT will act as the joint data controller for this study. This means that we are responsible for looking after your information and using it properly. UHSNHSFT will keep identifiable information about you for 20 years after the study has finished. We are collaborating with Queen Mary University of London, who will be responsible for processing your information and will also be acting as joint data controller.

The legal basis for collecting your data is based on general data protection regulation, specifically UK GDPR Articles 6.1.e and 9.2.j. Collecting data from this trial is in the public interest and the amount of data we are collecting is proportionate to the aims of the research study whilst also ensuring we safeguard your rights as a data subject.

As part of your agreement to participate in this trial, we explained how we would use your personal data in our Patient Information Sheet. That data is essential for us to get a clear result from the trial. Your rights to access, change or move your information are therefore limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. You can however withdraw from the study at any time without having to give a reason. You can do this by contacting your trial doctors or nurses as detailed on your Patient Information Sheet. If you withdraw from the study, we will keep the information about you that we have already obtained unless you ask us to delete it. To safeguard your rights, we will use the minimum personally-identifiable information possible.

No data will be transferred to any third countries or international organisations and you are under no statutory or contractual obligation to provide personal data. If you have any concerns about the care you receive or you wish to make a complaint you may contact your hospital’s Patient Advisory Liaison Service, or a relevant supervisory authority.

You can find out more about how we use your information below or by contacting the trial Chief Investigator Dr Mark Edwards at admin(at)floela.org. (please replace the (at) with the @ symbol when sending email). The data protection officer at Queen Mary University of London can be contacted at data-protection@qmul.ac.uk. The data protection officer at UHSNHSFT can be contacted at dataprotection@uhs.nhs.uk. If you wish to raise a complaint about the use of your information in this trial you can contact the Information Commissioner’s Office by visiting https:ico.org.uk/make-a-complaint/ or by telephoning 0303 123 1113.

How will we use information about you?
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. Nearly all the information that we need to look at for this trial is already collected by NHS and government organisations as a routine part of your care. These organisations hold confidential information so the way they handle information is tightly regulated and their databases will keep all information about you safe and secure. The organisations are:

•The Royal College of Anaesthetists; collects information about the care you receive while you are in hospital for this surgery for the National Emergency Laparotomy Audit (NELA); “the audit”.

•NHS England (or equivalent organisations in Wales and Scotland); holds information on hospital admissions (Hospital Episode Statistics) and mortality data sourced from Civil Registration Data and supplied by NHS England on behalf of the Office for National Statistics (ONS).

Nothing that might identify you will be revealed to parties other than the trial team at UHSNHSFT, QMUL, Sealed Envelope (the randomisation system provided by QMUL) and the organisations above. We will need to use information from your medical records for this research project. If you take part in this trial, authorised members of the research team will look at your hospital medical notes alongside your clinical team to enter information into the secure online NELA database. This will include a small amount of additional information about the treatment we gave you as part of the trial. The research team will also record some identifying information about you (NHS number, date of birth, gender and postcode) on a secure system provided by our Trials Unit at QMUL. People will use this information to do the research or to check your records to make sure that the research is being done properly. Getting information from the organisations above means we do not need to contact you to do this.

When the trial has finished, the Trials Unit at QMUL will request information about everyone who took part from both NELA and NHS England (or equivalent in Wales and Scotland). This is so that we can see whether the trial treatment was effective overall. To do this:

1. NELA will share data with us about your hospital care, for example the details of your surgery, how long you spent in hospital and the treatment you received as part of the trial. They do not need to send us personal information about you. Instead they will use a unique identification (ID) number that you will be given when you agree to take part in the trial.

2. Meanwhile the Trials Unit will send your identifying information as listed above to NHS England so that they can check your records and let us know your health status 90 days and one year after you were treated in the trial. The identifying information we send is the minimum amount we can use to make sure we get information about the right person. It is transferred securely to maintain confidentiality, and the information NHS England sends back uses your unique trial ID number but not your identifying information.

3. Information received from NELA and NHS England is combined at the Trials Unit, and any information that could identify you is removed. The unique ID number will be used to make sure the records from NELA and NHS England match each individual correctly. It will not be possible to identify individual trial participants when the results are released.

During the trial, authorised staff from the sponsor (University Hospital Southampton) or its representative (the Trials Unit at QMUL) may need to review your medical notes and NELA record in order to check that the trial is being carried out in line with approved procedures at your hospital. During this trial monitoring no further identifiable information about you will be recorded or removed from your hospital.

For patients in Wales, information will come from the ONS and the Patient Episode Database for Wales. In Scotland it will come from the NHS National Services Scotland Information Services Division.