Neomycine/Metronidazole- vs Rifaximin-based Gut Decolonisation Prior to Colon Surgery: a Randomized Multicenter Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 458
- 试验地点
- 4
- 主要终点
- Surgical Site Infection (deep and/or organ space)
研究概览
简要总结
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,
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 18 years
- •undergoind planned colon surgery
- •colon surgery will be included in Swissnoso SSI surveillance
- •informed consent
排除标准
- •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
研究组 & 干预措施
Metronidazol/Neomycin
Currently the most frequently used antibiotics for gut decolonisation prior to colon surgery (Standard of care)
干预措施: Metronidazole (Drug)
Metronidazol/Neomycin
Currently the most frequently used antibiotics for gut decolonisation prior to colon surgery (Standard of care)
干预措施: Neomycin Sulfate (Drug)
Rifaximin
Antibiotic with poorly systemic resorption after oral administration, under investigation as an agent for gut decolonization before colon surgery
干预措施: Rifaximin (Xifaxan) (Drug)
结局指标
主要结局
Surgical Site Infection (deep and/or organ space)
时间窗: 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.
次要结局
- Length of stay(up to 30 days after surgery)
- Mortality(up to 30 days after surgery)
研究者
Rami Sommerstein
Prof. Dr. Med.
Universität Luzern