Colon Surgery, Surgical Site Infection, Surgical Site Infections
Conditions
Keywords
SSI, surgical site infection, Metronidazol, flagyl, neomycine, rifaximin, colon surgery, antibiotics, preoperative decolonisation
Brief 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,
Detailed description
Surgical site infections (SSIs) are the most frequent infections in patients undergoing colon surgery, leading to considerable morbidity, mortality and increased healthcare costs. As SSIs are often caused by endogenous gut flora, oral antibiotic gut decolonisation prior to colon surgeries is standard practice. However the optimal antibiotic regimen remains unclear. This phase IV, multicenter, open-label randomized controlled trial aims to evaluate whether a rifaximin-based protocol is non-inferior to the current standard regimen of neomycin and metronidazole in preventing SSIs. Rifaximin is a semi-synthetic derivate with poor systemic absorption, allowing for local gut action and a broad antibacterial spectrum covering gram-positiv, - negativ, aerobic aswell as anaerobic bacteria. It is approved in Switzerland for hepatic encephalopathy and has a favorable safety profile with mostly mild gastrointestinal side effects. Neomycin is FDA-approved for preoperative gut decolonisation. Common side effects include nausea, vomiting and diarrhea. The study will include about 458 patients undergoing planned colon surgery at five swiss hospitals. Patients will be randomized in 1:1 ratio to receive either rifaximin 2x550mg per day or Neomycin 2x500mg plus Metronidazol 2x500mg per day, administeres orally at 10:00 AM and 10:00 PM on the day before surgery. Mechanical bowel preparation, when applied, is scheduled between 4:00 PM and 08:00 PM on the same day. The primary outcome is the incidence of SSI. Secondary outcomes include mortality and length of hospital stay. Ramdomization is computer-generated. Blinding is limited to the responsible statisticians. Clinicians and patients are aware of the assigned treatment. Safety assessments focus on known side effects as documentes by reculatory agencies. The study adresses a clinically important gap in evidence for the best antibiotic regimen for preoperative gut decolonisation.
Interventions
Preoperative gut decolonization protocol based on oral Rifaximin 2x550mg 10 am and 10 pm on the day preceding the surgery
DRUGMetronidazole
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
DRUGNeomycin Sulfate
Preoperative gut decolonization protocols based on oral Neomycine 2x500mg and Metronidazole 2x500mg 10 am and 10pm on the day preceding the surgery
Sponsors
Universität Luzern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The intervention will be conducted as an open-label randomized multicenter trial. The patients at the participating study sites will be individually randomized using a computer-generated randomization prior to surgery. It is an open-label trial, meaning that patients and heathcare providers are aware of the assigned treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (deep and/or organ space) | 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 surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | up to 30 days after surgery | To investigate the occurance of death |
| Length of stay | up to 30 days after surgery | Time of hospitalization after surgery |
Countries
Switzerland
Contacts
Primary ContactRami Sommerstein, Prof. Dr. Med.
Outcome results
None listed