Complications Clinical Trial
Official title:
Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome
Verified date | November 2011 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.
Status | Enrolling by invitation |
Enrollment | 90 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >= 18 years - Elective right hepatectomy - Elective extended right hepatectomy Exclusion Criteria: - Age < 18 years - Pregnancy - Other type of hepatectomy - Emergency hepatectomy |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Visceral Surgery, University Hospital CHUV | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Vaudois | University of Zurich |
Switzerland,
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. — View Citation
Paugam-Burtz C, Janny S, Delefosse D, Dahmani S, Dondero F, Mantz J, Belghiti J. Prospective validation of the "fifty-fifty" criteria as an early and accurate predictor of death after liver resection in intensive care unit patients. Ann Surg. 2009 Jan;249(1):124-8. doi: 10.1097/SLA.0b013e31819279cd. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Morbidity | Any type of complication defined according to the Clavien-Dindo Classification of surgical complications. | 90 days | Yes |
Secondary | Mortality | Patient death occuring 90 days post-operatively | 90 days | Yes |
Secondary | Liver failure | Defined according to the Belghiti 50-50 criteria for liver failure. | 90 days | Yes |
Secondary | Hospital stay | Total hospital stay (including re-admission hospital stay) in days | 90 days | No |
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