Effectiveness Of Symbiotic Therapy In Jaundiced Patients
This trial is active, not recruiting.
|Conditions||postoperative infections, jaundice|
|Sponsor||Azienda Ospedaliera Ordine Mauriziano di Torino|
|Start date||November 2008|
|Trial size||20 participants|
|Trial identifier||NCT01683708, Symbiotic2012|
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.
|Observational model||case control|
Infectious Morbidity Rate
time frame: Participants will followed for the duration of hospital stay, an expected average of 6 weeks
time frame: The day before and on postoperative day 7
RATE OF TRANSLOCATION
time frame: Intraoperative
Male or female participants from 18 years up to 80 years old.
Inclusion Criteria: - jaundiced patients scheduled for elective extrahepatic bile duct resections - age between 18 and 80 year-old Exclusion Criteria: Exclusion Criteria - cirrhosis - American Society of Anesthesiologists (ASA) score 4 - intestinal malabsorption - emergency surgery - intolerance to symbiotic - diagnosis of primary or secondary immunodeficiency - unresectability
|Official title||Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial|
|Principal investigator||Lorenzo Capussotti, MD|
|Description||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.|
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