Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Infectious Morbidity Rate
研究概览
简要总结
The aim of the present study was therefore to evaluate if the perioperative administration of symbiotics reduces postoperative infectious morbidity in jaundiced patients scheduled for hepato-biliary and pancreatic surgery.
详细描述
Despite advances in preoperative patient's selection and anesthetic and surgical techniques, surgery in jaundiced patients is associated with significant morbidity and mortality as a consequence of septic complications. The evidence that nosocomial infections are frequently a consequence of gut-derived organism such as enterobacteriaceae, supports the hypothesis of the "gut derived sepsis". Indeed, several studies have reported that jaundiced patients present an increased intestinal permeability and consequently a higher rate of bacterial migration from gastrointestinal tract across the lamina propria to local mesenteric lymph nodes and from there to extra-intestinal site. This phenomenon increases after surgical decompression of bile duct. The higher prevalence of bacterial translocation in jaundiced patients is related to different mechanisms such as mucosal atrophy secondary to protracted absence of intraluminal bile that open para-cellular route for bacterial translocation and the decreased clearance capacity of Kuppfer secondary to cholestasis.
The mechanisms of action of symbiotics are largely unknown. The probiotic bacteria can improve the mucosal barrier function reducing the bacterial translocation of organism to mesenteric lymph nodes. Indeed symbiotic can affect the intestinal ecosystem by stimulating mucosal immune and non-immune mechanisms through antagonism/competition with potential pathogens.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •jaundiced patients scheduled for elective extrahepatic bile duct resections
- •age between 18 and 80 year-old
排除标准
- •Exclusion Criteria
- •cirrhosis
- •American Society of Anesthesiologists (ASA) score 4
- •intestinal malabsorption
- •emergency surgery
- •intolerance to symbiotic
- •diagnosis of primary or secondary immunodeficiency
- •unresectability
结局指标
主要结局
Infectious Morbidity Rate
时间窗: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
次要结局
- IMMUNE PROFILE(The day before and on postoperative day 7)
- RATE OF TRANSLOCATION(Intraoperative)
研究者
LorenzoCapussotti
Director of Department of General and Oncologica Surgery
Azienda Ospedaliera Ordine Mauriziano di Torino
