CompletedInterventional

A clinical trial of blood flow optimisation for patients who have emergency bowel surgery

Emergency bowel surgery, known as an emergency laparotomy, is a major operation carried out for urgent abdominal problems like blockages, tears, or bleeding. During and after surgery, patients receive fluids through a drip to help keep blood flowing to their vital organs. Doctors usually check pulse and blood pressure to decide how much fluid to give. However, these standard checks do not always give the clearest picture. The FLO-ELA study is investigating whether using an extra heart monitor helps doctors tailor fluid amounts more accurately. This monitor tracks how much blood the heart pumps with each beat. Taking part involves having this extra monitoring during surgery and for six hours afterwards. Researchers want to see if this approach leads to fewer complications and helps patients spend more days safely recovered at home over the following three months.

At a glance

Status

Completed

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

3,138

Start

01 Jul 2017

Estimated completion

28 Nov 2024

Surgery - emergency laparotomy

What is this study about?

Emergency bowel surgery is a serious, unplanned operation. It is often needed when there is a sudden and dangerous problem in the abdomen, such as a burst bowel, a severe blockage, internal bleeding, or a spreading infection. During an operation like this, the body is under significant stress, and blood flow to vital organs like the kidneys and liver can drop. To protect these organs, doctors give fluids directly into a vein through a drip.

Getting the balance of fluids right is critical. Giving too little fluid can deprive organs of the oxygen they need to work properly, while giving too much can cause fluid to build up in the lungs and tissues. At present, doctors rely on standard measurements like blood pressure and heart rate to judge how much fluid a person needs. However, these signs can be influenced by many things and do not always tell doctors exactly how well the heart is pumping.

The FLO-ELA trial aims to find out if a more precise method improves recovery. Half of the patients in the trial receive usual care, while the other half have an extra monitor attached during surgery and for six hours afterwards. This monitor measures the exact amount of blood the heart pumps every minute, helping the anaesthetist and surgical team fine-tune the fluids given.

By comparing the two approaches across 50 NHS hospitals, the researchers hope to discover whether this extra guidance helps patients recover with fewer complications and reduces the time they need to spend in hospital.

Key takeaways

Tests whether an extra heart monitor helps doctors give the ideal amount of fluids during emergency bowel surgery.
Open to patients aged 50 and older having urgent or emergency abdominal operations in the NHS.
The study treatment lasts only during surgery and for six hours afterwards.
No extra hospital visits, blood tests, or medications are required.
Aims to reduce post-surgery complications and help patients get home sooner.

Who may be eligible?

This trial is open to adults aged 50 and over who need urgent or emergency surgery on their stomach, bowel, or abdomen. This includes operations needed within 24 hours to treat issues like torn bowel tissue, severe blockages, serious internal bleeding, or major abdominal infections. Participants must have an NHS number.

The study is not suitable for people having planned, routine operations. It also excludes people having standard appendix or gallbladder removals, simple hernia repairs that do not involve the bowel, gynaecological surgeries, or emergency operations caused by sudden physical injuries or accidents.

Because these operations happen quickly, the surgical team identifies eligible patients when emergency surgery is scheduled. Patients or their families will be given information about the study, and taking part is entirely voluntary.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 50 or over?
Do you need urgent or emergency surgery on your bowel or stomach within 24 hours?
Do you have an active NHS number?
Is your operation for a condition other than a routine appendix or gallbladder issue?
Is your surgery an emergency rather than a planned, elective procedure?

Answer every question to see your result.

What does participation involve?

Taking part takes place entirely during your planned hospital stay. When you go into theatre, you are randomly placed into one of two groups: one receives standard NHS fluid care, and the other receives fluid guided by the extra heart monitor. Both treatments start when you go to sleep under general anaesthetic and end six hours after your operation finishes. Your surgical care and hospital stay will otherwise be identical, and you do not need to take any new tablets, travel to extra appointments, or undergo extra scans. After you leave hospital, researchers simply check your recovery over the next 90 days using routinely collected NHS records.

Potential risks and benefits

Previous studies suggest that guided fluid therapy is safe and may help reduce common post-surgery complications, such as kidney problems or chest infections. However, there is no guarantee that taking part will directly help your individual recovery. You will be closely watched by specialist doctors and anaesthetists throughout your surgery, and they can adjust your fluids at any time to keep you safe. You are free to withdraw from the trial at any point, and choosing not to take part will never affect the quality of your NHS care.

Locations (39)

University Hospital Southampton
City only
Southampton, England
Russells Hall Hospital
Approximate
Dudley, England
Derriford Hospital
Approximate
Plymouth, England
Royal Free Hospital
Approximate
London, England
Medway Maritime Hospital
Approximate
Gillingham, England
Harrogate District Hospital
Unverified
Harrogate, England
Warwick Hospital
Unverified
Warwick, England
Sherwood Forest Hospitals NHS Foundation Trust
Unverified
Sutton-in-ashfield, England
Torbay Hospital
Unverified
Torquay, England
Conquest Hospital
Unverified
St. Leonards-on-sea, England
King's Mill Hospital
Unverified
Sutton-in-Ashfield, England
Watford General Hospital
Unverified
Watford, England

Common questions

Will I know which treatment group I am in?

Probably not. Both groups receive fluids through a standard drip while under anaesthetic and during early recovery, so your experience in hospital will feel the same either way.

Does taking part mean I have to stay in hospital longer?

No. The trial treatment only lasts for six hours after your surgery ends. You will be discharged from hospital as soon as your surgical team decides you are well enough.

Are there any extra tests or clinic visits afterwards?

No. Researchers follow your recovery by looking at your standard NHS medical notes, so you do not need to attend any extra hospital appointments for the trial.

What happens if I am too unwell to give consent before surgery?

Because this is emergency surgery, doctors may ask your family or an independent doctor to agree on your behalf. You will be given full information and the chance to confirm or withdraw your consent once you are awake and feeling better.

Why is the study only for people aged 50 and older?

Older adults have a higher chance of developing complications during major bowel surgery. Testing this approach in this age group helps researchers find out where it can do the most good.

How to find out more

Zoe Clark

zoe.clark@uhs.nhs.uk +44 (0)23 8120 1863 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.