Hepatectomy Clinical Trial
Official title:
Validation of Our Policy of Long-term Drains Maintenance After Hepatic Resection: Results of a Prospective Cohort Analysis
Verified date | February 2014 |
Source | University of Milan |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Observational [Patient Registry] |
The definition of biliary fistula is heterogeneous and the more accepted is that proposed by the ISGLS. We devised a precise definition of post-resectional biliary fistula and a well-established policy both for its disclosure and management.Aim was the validation of our definition, and management of biliary fistula after hepatic resection in a large prospective cohort of patients and its comparison with that of the International Study Group of Liver Surgery (ISGLS).
Status | Completed |
Enrollment | 475 |
Est. completion date | February 2014 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - any patient submitted to hepatic resection at our Unit between the established frame time Exclusion Criteria: - any patient with incomplete data or follow-up |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Humanitas Research Hospital | Rozzano, Milan |
Lead Sponsor | Collaborator |
---|---|
University of Milan |
Italy,
Torzilli G, Olivari N, Del Fabbro D, Gambetti A, Leoni P, Gendarini A, Makuuchi M. Bilirubin level fluctuation in drain discharge after hepatectomies justifies long-term drain maintenance. Hepatogastroenterology. 2005 Jul-Aug;52(64):1206-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bile leak | The first study endpoint was the ability of our criteria to detect and manage bile leak after liver surgery. For this purpose we considered the rate of bile leaks detected and managed using the surgical drains, and the rate of abdominal collections that required any surgical or radiological intervention after drains removal. | 7 days | No |
Secondary | ISGLS definition | The second endpoint was the exploration of the ISGLS definition of bile leak in the herein presented cohort of patients in regards of the rate of bile leaks and abdominal collections. | 7 days | No |
Secondary | ISGLS definition | Exploration of reliability and efficacy of the International Study Group on Liver Surgery (ISGLS) definition of bile leak after hepatectomy | 90 days | No |
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