Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Luzern
About this trial
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,
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged ≥ 18 years
undergoind planned colon surgery
colon surgery will be included in Swissnoso SSI surveillance
informed consent
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rifaximin (Xifaxan)
DrugPreoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery
Metronidazole
DrugPreoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
Neomycin Sulfate
DrugPreoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
Treatment groups
458 Participants
are divided into 2 treatment groupsGroup A: Metronidazol/NeomycinActive comparator 2 interventions
Group B: RifaximinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Site Infection (deep and/or organ space)
Assessment of surgical site infection (SSI) is following Swissnoso standard procedures and comprises a routine surveillance for means of quality control in all participating centers, irrespective of participation in this study. In brief, IP nurses supervised by infectious diseases specialists or other physicians without hierarchical link with the departments of surgery are in charge of the surveillance in each participating hospital. Patients are followed-up by IP nurses during their hospital stay and post-discharge for 30 days. Any suspicion of SSI or unclear situation is presented to the supervising physician for decision about the diagnosis of SSI. The post-discharge follow-up is done performed by IP nurses through standardized phone interviews with the patients. CDC critiera will be applied to determine the presence of SSI.
Time frame
The occurrence of surgical site infections is evaluated at two time points: 1. At time of dismissal from the hospital (up to d30) 2. If the patients is discharged: Via post-discharge surveillance at 30 days after surgerySecondary outcomes
1
Mortality
To investigate the occurance of death
Time frame
up to 30 days after surgery2
Length of stay
Time of hospitalization after surgery
Time frame
up to 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: