Colo-Pro_2: Bolus-continuous Infusion Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery

Launched by UNIVERSITY OF LEEDS · Nov 7, 2022

Keywords

ClinConnect Summary

The Colo-Pro_2 trial is studying how to prevent infections after colorectal surgery by using an antibiotic called cefuroxime. When patients have surgery, they often receive a single dose of antibiotics beforehand to help reduce the risk of infections. However, the levels of the antibiotic can drop during the surgery, which may not provide enough protection. This trial aims to find out if giving a single dose of cefuroxime followed by a continuous infusion during the surgery is more effective at preventing infections compared to just the single dose. The trial will involve up to 180 patients across three hospitals, allowing researchers to see if the results are consistent in different settings.

To participate in this trial, patients must be at least 16 years old and scheduled for elective colorectal surgery that is expected to last more than two hours. They should also have adequate kidney function and be capable of providing informed consent. Throughout the study, participants will receive the same antibiotic, and the medical team will monitor for infections for up to 30 days after surgery. Importantly, the medical staff assessing the outcomes will not know which treatment each patient received, helping to ensure unbiased results. This research is important as it could lead to better infection prevention strategies for patients undergoing bowel surgeries.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Undergoing elective colorectal surgery (incision, excision or anastomosis of the large bowel, including anastomosis of small to large bowel)
• • Age \>16.
• • Expected duration of surgery \> 2hours
• • Creatinine clearance \> 40 ml/min
• • Cefuroxime/metronidazole are appropriate antibiotic prophylaxis regimens.
• • Patient capable of giving informed consent
• • Patients undergoing colorectal surgery plus additional surgery e.g. plastic surgery, urological surgery, gynaecological surgery.
• Exclusion Criteria:
• • Unable to consent
• • Pregnancy
• • Expected duration of surgery \<2hours
• • Creatinine clearance \<40ml/min
• • Individual level microbiological advice for non-cefuroxime based prophylaxis
• • Cephalosporin allergy
• • Penicillin allergy (hypersensitivity reaction only)
• • Coumarin (warfarin and acenocoumarol) treatment
• • Seizure history or epilepsy
• • Concurrent use of probenecid
• • Current participation in a research project aimed at reducing surgical site infections (SSIs)
• • Antibiotics for treatment of a systemic Gram negative infection within 12 hours of initiation of surgery (Vancomycin, Teicoplanin, Daptomycin, Linezolid, Flucloxacillin. Nitrofurantoin and Clarithromycin would be permissible antibiotics without systemic Gram negative antibiotics).
• • A current diagnosis of infection at the time of study entry.
• • STARR procedures (stapled trans anal resection of the rectum)
• • Weight \<30kg or \>110kg