Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Mark Edwards
-
admin@floela.org


Ms Zoe Clark
+44 (0)23 8120 1863
zoe.clark@uhs.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - A clinical trial of blood flow optimisation for patients who have emergency bowel surgery

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

Medical Conditions

Surgery - emergency laparotomy


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Emergency bowel surgery (laparotomy) is a major procedure which can lead to reduced blood flow to vital organs. This can lead to complications after surgery. Fluids are given into the bloodstream (intravenous) to improve blood flow. Giving the right amount of this intravenous fluid at the right time is important for recovery after surgery, but is hard to gauge accurately. Doctors normally use signs such as heart rate and blood pressure to guide them, but these can be unreliable. Previous research has shown that a treatment used during surgery and shortly afterwards may improve the amount of oxygen delivered to the body’s tissues and reduce the number of patients who develop complications after surgery. This treatment involves using a heart monitor (cardiac output monitor) to help clinical teams decide the amount and timing of intravenous fluid to give to patients. There is some evidence from smaller studies that this treatment is beneficial, but this needs to be confirmed in a much larger study. The aim of this study is to find out whether the use of cardiac output monitoring to guide the use of intravenous fluid increases the number of days spent alive and out of hospital within 90 days of randomisation compared with usual care.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jul 2017 28 Nov 2024

Publications

2023 Protocol article in https://doi.org/10.1186/s13063-023-07275-3 (added 09/05/2023)

During and after surgery, participants are randomly allocated to receive one of the treatments, either the study treatment or usual care. Participants' experiences are the same regardless of which treatment they receive, and they probably won’t be able to tell which one they are getting. Both treatments begin at the start of surgery and finish six hours after it has ended. The two treatments involve slightly different ways of deciding the amount of intravenous fluid participants receive. If they receive usual care their doctor uses measurements such as heart rate and blood pressure to guide this. If they receive the new study treatment their clinical team also measures the amount of blood their heart pumps each minute using an extra monitor. These extra measurements help the doctor to decide how much intravenous fluid they give. After the treatment is over, care continues as normal and there is no need to contact the participants further. Routinely collected information from medical notes and NHS databases is used to follow-up participants' recovery after surgery.


Patients aged 50 and over undergoing emergency laparotomy

You can take part if:



You may not be able to take part if:


1. Refusal of patient consent2. Clinician refusal3. Previous enrolment in the FLO-ELA trial4. Previous inclusion in NELA within the current hospital admission5. Current participation in another clinical trial of a treatment with a similar biological mechanism6. Scheduled abdominal procedure outside the scope of NELA, including: elective procedures, uncomplicated appendicectomy or cholecystectomy, non-elective hernia repair without bowel resection, vascular surgery, including abdominal aortic aneurysm repair, Caesarean section, obstetric laparotomies or gynaecological laparotomy, or laparotomy/laparoscopy for pathology caused by trauma


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • Croydon University Hospital
    London Road
    Croydon
    CR7 7YE
  • University Hospital of Wales
    Heath Park
    Cardiff
    CF14 4XW
  • Royal United Hospitals Bath NHS Foundation Trust
    Combe Park
    Bath
    BA1 3NG
  • Royal Free Hospital
    London
    NW3 2QG
  • Queens Hospital
    Rom Valley Way
    Romford
    RM7 0AG
  • Derriford Hospital
    Derriford Road Derriford
    Plymouth
    PL6 8DH
  • Royal Derby Hospital
    Uttoxeter Road
    Derby
    DE22 3NE
  • University Hospital Southampton
    Southampton University Hospital Tremona Road
    Southampton
    SO16 6YD
  • Russells Hall Hospital
    Pensnett Road
    Dudley
    DY1 2HQ
  • Medway Maritime Hospital
    Gillingham
    ME7 5NY
  • Harrogate District Hospital
    Harrogate
    HG2 7SX
  • Warwick Hospital
    Warwick
    CV34 5BW
  • Sherwood Forest Hospitals
    Mansfield
    NG17 4JL
  • Torbay Hospital
    Torbay
    TQ2 7AA
  • Conquest Hospital
    St Leonards-on-Sea
    TN37 7PT
  • King's Mill Hospital
    Mansfield Rd
    Sutton-in-Ashfield
    NG17 4JL
  • Watford General Hospital
    Vicarage Road
    Watford
    WD18 0HB
  • St Thomas' Hospital
    Westminster Bridge Rd
    London
    SE1 7EH
  • St James University Hospital NHS Trust
    St James's University Hospital Gledow Wing Beckett Street
    Leeds
    LS9 7TF
  • University Hospital Birmingham
    Queen Elizabeth Hospital Edgbaston
    Birmingham
    B15 2TH
  • Royal London Hospital and Associated Community Services NHS Trust
    The Royal London Hospital Whitechapel
    London
    E1 1BB
  • The Royal Victoria Infirmary
    Queen Victoria Road
    Newcastle upon Tyne
    TS1 4LP
  • Sunderland Royal Hospital
    Kayll Road
    Sunderland
    SR4 7TP
  • University Hospital Lewisham
    Lewisham High Street
    London
    SE13 6LH
  • Mersey Care NHS Trust at Aintree Hospital
    C/o University Hospital Aintree Fazakerley Hospital Lower Lane
    Liverpool
    L9 7AL
  • Queens Hospital
    Belvedere Road
    Burton-on-trent
    DE13 0RB
  • Royal Bournemouth General Hospital
    Castle Lane East
    Bournemouth
    BH7 7DW
  • Southport District General Hospital
    Town Lane Kew
    Southport
    PR8 6NJ
  • University Hospital of North Durham
    University Hospital of Durham Dryburn Hospital North Road
    Durham
    DH1 5TW
  • St George's at Kings College Hospital
    Denmark Hill
    London
    SE5 9RS
  • Northwick Park and St Marks NHS Trust
    Northwick Park Hospital Watford Road
    Harrow
    HA1 3UJ
  • William Harvey Hospital
    Kennington Road Willesborough
    Ashford
    TN24 0LZ
  • Norfolk & Norwich University Hospital
    Colney Lane Colney
    Norwich
    NR4 7UY
  • Worcestershire Royal Hospital
    Charles Hastings Way
    Worcester
    WR5 1DD
  • Royal Shrewsbury Hospital
    Mytton Oak Road
    Shrewsbury
    SY3 8XQ
  • Manchester Royal Royal Infirmary
    Cobbett House Oxford Road
    Manchester
    M13 9WL
  • Whipps Cross Hospital
    Whipps Cross Road
    London
    E11 1NR
  • Victoria Hospital
    Hayfield Road
    Kirkcaldy
    KY2 5AH

Previous research suggests that the treatment is safe and should benefit most patients. Participants are closely monitored throughout the study and, if necessary, their clinical team makes adjustments to their treatment to make sure they are safe.

Dr Mark Edwards
-
admin@floela.org


Ms Zoe Clark
+44 (0)23 8120 1863
zoe.clark@uhs.nhs.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University Hospital Southampton NHS Foundation Trust and funded by Health Technology Assessment Programme.




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Read full details for Trial ID: ISRCTN14729158

Or CPMS 33869

Last updated 16 January 2025

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