Effectiveness Of Symbiotic Therapy In Jaundiced Patients
Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
1 other identifier
observational
20
0 countries
N/A
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.
Trial Health
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participants targeted
Target at below P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 7, 2012
CompletedFirst Posted
Study publicly available on registry
September 12, 2012
CompletedSeptember 12, 2012
September 1, 2012
September 7, 2012
September 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infectious Morbidity Rate
Participants will followed for the duration of hospital stay, an expected average of 6 weeks
Secondary Outcomes (2)
IMMUNE PROFILE
The day before and on postoperative day 7
RATE OF TRANSLOCATION
Intraoperative
Study Arms (2)
Symbiotic group
Jaundiced patients who have symbiotic therapy
No Symbiotic therapy
Jaundiced patients who not have symbiotic therapy
Interventions
Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr).
Eligibility Criteria
Jaundiced patients scheduled for hepato-biliary pancreatic surgery
You may qualify if:
- jaundiced patients scheduled for elective extrahepatic bile duct resections
You may not qualify if:
- cirrhosis
- American Society of Anesthesiologists (ASA) score 4
- intestinal malabsorption
- emergency surgery
- intolerance to symbiotic
- diagnosis of primary or secondary immunodeficiency
- unresectability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Sugawara G, Nagino M, Nishio H, Ebata T, Takagi K, Asahara T, Nomoto K, Nimura Y. Perioperative synbiotic treatment to prevent postoperative infectious complications in biliary cancer surgery: a randomized controlled trial. Ann Surg. 2006 Nov;244(5):706-14. doi: 10.1097/01.sla.0000219039.20924.88.
PMID: 17060763RESULTKanazawa H, Nagino M, Kamiya S, Komatsu S, Mayumi T, Takagi K, Asahara T, Nomoto K, Tanaka R, Nimura Y. Synbiotics reduce postoperative infectious complications: a randomized controlled trial in biliary cancer patients undergoing hepatectomy. Langenbecks Arch Surg. 2005 Apr;390(2):104-13. doi: 10.1007/s00423-004-0536-1. Epub 2005 Feb 12.
PMID: 15711820RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lorenzo Capussotti, MD
Mauriziano Hospital, Department of General and Oncological surgery
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Department of General and Oncologica Surgery
Study Record Dates
First Submitted
September 7, 2012
First Posted
September 12, 2012
Study Start
November 1, 2008
Last Updated
September 12, 2012
Record last verified: 2012-09