Jaundice Clinical Trial
Official title:
Effectiveness of Perioperative Symbiotic Therapy to Reduce Infectious Morbidity in Jaundiced Patients: a Randomized Controlled Trial
Verified date | September 2012 |
Source | Azienda Ospedaliera Ordine Mauriziano di Torino |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Ordine Mauriziano di Torino |
Kanazawa 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 — View Citation
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):706-1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious Morbidity Rate | Participants will followed for the duration of hospital stay, an expected average of 6 weeks | Yes | |
Secondary | IMMUNE PROFILE | The day before and on postoperative day 7 | Yes | |
Secondary | RATE OF TRANSLOCATION | a lymph node was routinely excised from the ileocaecal mesentery and was immediately transported in sterile saline to the laboratory for culture | Intraoperative | Yes |
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