Using Cefuroxime to Prevent Infections After Colorectal Surgery
Colo-Pro_2: A Feasibility Randomised Controlled Double Blind Trial to Compare Standard Bolus Dosed Cefuroxime Prophylaxis to Bolus-continuous Infusion Dosed Cefuroxime Prophylaxis for the Prevention of Infections After Colorectal Surgery
This study tests if giving a continuous dose of cefuroxime before and during colorectal surgery can help prevent infections after the operation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Locations | 3 sites (Birmingham, West Midlands and 2 other locations) |
| Trial ID | NCT05609240 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a bolus-continuous infusion of cefuroxime as a prophylactic measure to prevent infections following colorectal surgery. Patients undergoing elective colorectal procedures will receive a single dose of cefuroxime before surgery, followed by a continuous infusion throughout the operation. The aim is to maintain adequate antibiotic levels during surgery to reduce the risk of postoperative infections. The study builds on previous findings that indicated patient willingness to participate and the safety of the approach.
Who should consider this trial
Good fit: Ideal candidates include adults over 16 years old who are scheduled for elective colorectal surgery lasting more than two hours and have adequate kidney function.
Not a fit: Patients who are pregnant, have certain allergies to antibiotics, or have a history of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections after colorectal surgery, improving patient outcomes.
How similar studies have performed: Previous studies have shown promise in using continuous antibiotic infusion during surgery, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, West Midlands and 2 other locations
- TheUniversity of Birmingham — Birmingham, West Midlands, United Kingdom (Not_yet_recruiting)
- Leeds Teaching Hospitals — Leeds, West Yorkshire, United Kingdom (Recruiting)
- Aneurin Bevan University Health Board — Newport, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Andrew Kirby
- Email: a.kirby@leeds.ac.uk
- Phone: 01133923929
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.