Effectiveness Of Symbiotic Therapy In Jaundiced Patients

• Conditions: Postoperative Infections; Jaundice
• Interventions: Dietary Supplement: Symbiotic therapy

• Registration Number: NCT01683708
• Lead Sponsor: Azienda Ospedaliera Ordine Mauriziano di Torino

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-11
• Status Verified: 2012-09
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-10
• Last Update Submitted: 2012-09-10
• Study First Posted: 2012-09-12
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symbiotic group	Symbiotic therapy	Jaundiced patients who have symbiotic therapy

Primary Outcome Measures

Name	Time	Method
Infectious Morbidity Rate	Participants will followed for the duration of hospital stay, an expected average of 6 weeks

Secondary Outcome Measures

Name	Time	Method
IMMUNE PROFILE	The day before and on postoperative day 7
RATE OF TRANSLOCATION	Intraoperative	a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture