Comparison of Two Antibiotics for Bowel Decontamination Before Colorectal Surgery: A Clinical Study
Zusammenfassung der Studie
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)
Untersuchte Intervention
Bowel decolonization with Rifaximin or Neomycin/Metronidazole
(BASEC)
Untersuchte Krankheit(en)
Postoperative Wound Infections
(BASEC)
- Age ≥ 18 years - Planned colon surgery - Colon surgery included in the Swissnoso-SSI monitoring - Informed consent (BASEC)
Ausschlusskriterien
- 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)
Studienstandort
Aarau, Luzern, Zürich
(BASEC)
Sponsor
- Institutional funding and by the Hirslanden Research Foundation
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Rami Sommerstein
+41 41 208 32 54
rami.sommerstein@clutterunilu.chUniversity of Lucerne
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.01.2026
(BASEC)
ICTRP Studien-ID
NCT07180615 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Neomycine/Metronidazole vs Rifaximin-based Gut Decolonisation prior to Colon Surgery: a Randomized Multicenter Trial (BASEC)
Wissenschaftlicher Titel
Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial (ICTRP)
Öffentlicher Titel
Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery (ICTRP)
Untersuchte Krankheit(en)
Surgical Site InfectionColon SurgerySurgical Site Infections (ICTRP)
Untersuchte Intervention
Drug: Rifaximin (Xifaxan)Drug: MetronidazoleDrug: Neomycin Sulfate (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
Surgical Site Infection (deep and/or organ space) (ICTRP)
Mortality;Length of stay (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Rami Sommerstein, Prof. Dr. Med., rami.sommerstein@unilu.ch, +41 41 208 32 54 (ICTRP)
Sekundäre IDs
2025-01074 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT07180615 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar