Colo-Pro_2: Bolus-continuous infusion surgical antibiotic prophylaxis

  • Research type

    Research Study

  • Full title

    Colo-Pro_2: A feasibility randomised controlled double blinded trial to compare standard bolus dosed cefuroxime prophylaxis to bolus-continuous infusion dosed cefuroxime prophylaxis for the prevention of infections after colorectal surgery.

  • IRAS ID

    315251

  • Contact name

    Andrew Kirby

  • Contact email

    a.kirby@leeds.ac.uk

  • Sponsor organisation

    University of Leeds

  • Clinicaltrials.gov Identifier

    NCT05609240

  • Duration of Study in the UK

    2 years, 3 months, 0 days

  • Research summary

    Patients in hospital can have operations as part of their care. After a surgical operation patients may have an infection in the operation wound, the bladder, kidneys or lungs. To stop these infections patients are given a dose of antibiotic before their operation. Operations can be very long. During operations antibiotic levels drop because the kidneys remove drugs from the body. This means that the level of the drug can be too low to stop bugs from growing. A way of maintaining antibiotic levels throughout an operation is to give a single dose of antibiotic and then a constant amount of antibiotic by an infusion from the start to the end of the operation.

    We previously carried out a small single centre test study into antibiotic dosing during bowel operations. One group of patients had a single dose of antibiotic before their operation. The other group had a single dose plus a constant dose of antibiotic until the end of their operation. The study helped us identify the correct amounts of antibiotic needed for the patients given the single dose plus a constant dose of antibiotic.

    We will build on the single centre study with a larger study. It will be run in three hospitals so we can see if our methods work at different hospitals. All patients will be given the same antibiotic which is called cefuroxime. One group of patients will get cefuroxime as a single dose every 4 hours, the other group will get a single dose and an infusion throughout their operation. We will count infections that happen after operations. To make counting the infections fair, we hope patients and the staff looking after them are not aware which of the treatments patients received, and we will monitor this throughout the trial.

  • REC name

    North West - Greater Manchester West Research Ethics Committee

  • REC reference

    22/NW/0357

  • Date of REC Opinion

    8 Dec 2022

  • REC opinion

    Further Information Favourable Opinion