Comparison of Two Antibiotics for Bowel Decontamination Before Colorectal Surgery: A Clinical Study
Descrizione riassuntiva dello studio
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)
Intervento studiato
Bowel decolonization with Rifaximin or Neomycin/Metronidazole
(BASEC)
Malattie studiate
Postoperative Wound Infections
(BASEC)
- Age ≥ 18 years - Planned colon surgery - Colon surgery included in the Swissnoso-SSI monitoring - Informed consent (BASEC)
Criteri di esclusione
- 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)
Luogo dello studio
Aarau, Luzern, Zurigo
(BASEC)
Sponsor
- Institutional funding and by the Hirslanden Research Foundation
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Rami Sommerstein
+41 41 208 32 54
rami.sommerstein@clutterunilu.chUniversity of Lucerne
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
23.01.2026
(BASEC)
ID di studio ICTRP
NCT07180615 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Neomycine/Metronidazole vs Rifaximin-based Gut Decolonisation prior to Colon Surgery: a Randomized Multicenter Trial (BASEC)
Titolo accademico
Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial (ICTRP)
Titolo pubblico
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery (ICTRP)
Malattie studiate
Surgical Site InfectionColon SurgerySurgical Site Infections (ICTRP)
Intervento studiato
Drug: Rifaximin (Xifaxan)Drug: MetronidazoleDrug: Neomycin Sulfate (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
Surgical Site Infection (deep and/or organ space) (ICTRP)
Mortality;Length of stay (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Rami Sommerstein, Prof. Dr. Med., rami.sommerstein@unilu.ch, +41 41 208 32 54 (ICTRP)
ID secondari
2025-01074 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT07180615 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile