Comparison of Two Antibiotics for Bowel Decontamination Before Colorectal Surgery: A Clinical Study
Summary description of the study
Wound infections after colorectal surgeries are common hospital infections and lead to increased morbidity, mortality, and costs. The risk of infection is particularly high in colorectal surgeries. Since infections are often caused by bacteria from the normal gut flora, bowel decontamination with antibiotics before such surgery is common practice. Hospitals use various protocols that have never been compared before. This randomized study investigates whether antibiotic therapy with Rifaximin is as effective against wound infection as the most commonly used protocol with Neomycin and Metronidazole. At least 458 patients will be randomly assigned to two groups. One group will receive Rifaximin, and the other Neomycin/Metronidazole, each on the day before the surgery. The allocation is done per patient using a random generator. A telephone follow-up will occur 30 days after the surgery. The primary outcome is the proportion of patients with a wound infection. Additionally, infection rates will be analyzed concerning the depth of infection, type of procedure, and other factors such as mortality. Possible side effects of the medications used will also be recorded. Included are men and women aged 18 years and older who are undergoing a planned colorectal surgery. Exclusion criteria include intolerances to the medications used, active infections at the time of the procedure, lack of consent for data use, or pregnancy.
(BASEC)
Intervention under investigation
Bowel decolonization with Rifaximin or Neomycin/Metronidazole
(BASEC)
Disease under investigation
Postoperative Wound Infections
(BASEC)
- Age ≥ 18 years - Planned colon surgery - Colon surgery included in the Swissnoso-SSI monitoring - Informed consent (BASEC)
Exclusion criteria
- Known contraindications and/or intolerance to any of the study drugs, extended to cross-reactivity (e.g., aminoglycosides other than Neomycin; all rifamycins; all nitroimidazoles) - Patients with an underlying active infection (wound contamination Class IV) or uncontrolled sepsis requiring systemic antibiotic therapy - Multivisceral resection - Pregnant women - Breastfeeding women - Severe liver dysfunction (e.g., Child-Pugh C) - Active or recently (within 6 weeks) occurred C. difficile infection - Recent systemic rifamycin exposure (< 3 months) or anticipated need for rifampin within 3 months after surgery - Severe immunosuppression (definition, Appendix 2) - Concurrent medication with strong interaction with Rifaximin (especially Cyclosporine). - Inability to comply with the study protocol (BASEC)
Trial sites
Aarau, Luzern, Zurich
(BASEC)
Sponsor
- Institutional funding and by the Hirslanden Research Foundation
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Rami Sommerstein
+41 41 208 32 54
rami.sommerstein@clutterunilu.chUniversity of Lucerne
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
23.01.2026
(BASEC)
ICTRP Trial ID
NCT07180615 (ICTRP)
Official title (approved by ethics committee)
Neomycine/Metronidazole vs Rifaximin-based Gut Decolonisation prior to Colon Surgery: a Randomized Multicenter Trial (BASEC)
Academic title
Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial (ICTRP)
Public title
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery (ICTRP)
Disease under investigation
Surgical Site InfectionColon SurgerySurgical Site Infections (ICTRP)
Intervention under investigation
Drug: Rifaximin (Xifaxan)Drug: MetronidazoleDrug: Neomycin Sulfate (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- aged = 18 years
- undergoind planned colon surgery
- colon surgery will be included in Swissnoso SSI surveillance
- informed consent
Exclusion Criteria:
- contraindications and/or intolerance to one of the study compounds
- patients with underlying active infection (wound contamination class IV) at the
timepoint of incision
- pregnant women
- unable to follow study protocol (ICTRP)
not available
Primary and secondary end points
Surgical Site Infection (deep and/or organ space) (ICTRP)
Mortality;Length of stay (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Rami Sommerstein, Prof. Dr. Med., rami.sommerstein@unilu.ch, +41 41 208 32 54 (ICTRP)
Secondary trial IDs
2025-01074 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT07180615 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available