跳至主要内容
临床试验/NCT01683708
NCT01683708Unknown不适用

Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial

Azienda Ospedaliera Ordine Mauriziano di Torino0 个研究点目标入组 20 人开始时间: 2008年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

LorenzoCapussotti

Director of Department of General and Oncologica Surgery

Azienda Ospedaliera Ordine Mauriziano di Torino

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