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Right Hepatectomy in Patients Beyond 70 Years Old

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ClinicalTrials.gov Identifier: NCT01471262
Recruitment Status : Unknown
Verified November 2011 by Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Enrolling by invitation
First Posted : November 15, 2011
Last Update Posted : November 22, 2011
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois

Brief Summary:
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.

Condition or disease Intervention/treatment
Complications Liver Failure, Acute Procedure: Right hepatectomy Procedure: Extended right hepatectomy

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome
Study Start Date : January 2006
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Group/Cohort Intervention/treatment
Elderly
Patients more or equal to 70 years old
Procedure: Right hepatectomy
Right liver resection
Other Name: Liver surgery

Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Name: Liver surgery

Young
Patients less than 70 years old
Procedure: Right hepatectomy
Right liver resection
Other Name: Liver surgery

Procedure: Extended right hepatectomy
Right hepatectomy involving 5 or more segments
Other Name: Liver surgery




Primary Outcome Measures :
  1. Morbidity [ Time Frame: 90 days ]
    Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    Patient death occuring 90 days post-operatively

  2. Liver failure [ Time Frame: 90 days ]
    Defined according to the Belghiti 50-50 criteria for liver failure.

  3. Hospital stay [ Time Frame: 90 days ]
    Total hospital stay (including re-admission hospital stay) in days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients that will undergo right or extended right hepatectomy for benign or malignant diseases.
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Elective right hepatectomy
  • Elective extended right hepatectomy

Exclusion Criteria:

  • Age < 18 years
  • Pregnancy
  • Other type of hepatectomy
  • Emergency hepatectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471262


Locations
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Switzerland
Department of Visceral Surgery, University Hospital CHUV
Lausanne, Switzerland, CH-1012
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
University of Zurich
Investigators
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Principal Investigator: Emmanuel Melloul, MD Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
Study Chair: Nicolas Demartines, MD Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
Publications:
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Responsible Party: Dr. Emmanuel Melloul, Medical Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01471262    
Other Study ID Numbers: CHV080501
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011
Keywords provided by Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois:
Complications
Mortality
Liver
Failure
Additional relevant MeSH terms:
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Liver Failure
Liver Failure, Acute
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics