Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
NCT07180615 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 458
Last updated 2025-09-18
Summary
The goal of this clinical trial is to find out if a gut cleaning using Rifaximin works as well as the usual treatment with Neomycin and Metronidazole to prevent infections after colon surgery. The study includes adult patients who will have colon surgery.
The main question it aims to answer are:
-Does the Rifaximin treatment prevent surgical site infections as well as the Neomycin/Metronidazole treatment?
Other things the study will look at:
* How often infections happen, stratified on how deep they are, the type of surgery the patients got, or if bowel cleaning was done before surgery.
* How many people will die after surgery
* How long people stay in hospital
Participants will:
* Take either Rifaximin or Neomycin/Metronidazole one day before surgery to clean their gut
* Keep a diary until the surgery to record medication intake and any side effects
* Be contacted by phone 30 days after surgery to ask about their condition and any side effects,
Conditions
- Surgical Site Infection
- Colon Surgery
- Surgical Site Infections
Interventions
- DRUG
-
Rifaximin (Xifaxan)
Preoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery
- DRUG
-
Metronidazole
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
- DRUG
-
Neomycin Sulfate
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
Sponsors & Collaborators
-
Universität Luzern
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2028-01-01
- Completion
- 2029-06-30
- FDA Drug
- Yes
Countries
- Switzerland
Study Locations
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