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
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
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.
Results Summary
Before colorectal surgery, patients are routinely given antibiotics to reduce the risk of infection after the operation. The standard approach is to give a single dose of antibiotics before surgery, followed by additional doses at set intervals during the procedure. Researchers are exploring whether a different method — giving an initial dose followed by a continuous infusion of antibiotics throughout the surgery — might keep antibiotic levels in the body more stable and potentially improve protection against infection. Because this approach is new, the first step is to find out whether it is practical to test it in a larger clinical trial.This feasibility study took place in five hospitals across the UK. It involved adults having planned colorectal surgery expected to last more than two hours. Participants were randomly assigned to one of two groups. The control group received the usual treatment: a standard dose of the antibiotic cefuroxime before surgery and repeat doses every four hours. The experimental group received cefuroxime as a continuous infusion designed to maintain a steady level of the drug in the bloodstream.
Between May 2023 and December 2024, the study recruited 175 people, and 167 went on to receive one of the two treatments during surgery. On average, each hospital recruited around three to four participants per month. Infection rates within 30 days of surgery were similar between the two groups. Only one case of C. difficile infection occurred in the control arm only, and no safety concerns were identified with the higher antibiotic exposure in the continuous‑infusion group.
These findings show that running a larger trial of this new antibiotic approach is feasible.
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