Optimization of Health Expenditure in Liver Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01715402|
Recruitment Status : Unknown
Verified February 2017 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was: Enrolling by invitation
First Posted : October 29, 2012
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment|
|Hepatocellular Carcinoma Hilar Cholangiocarcinoma Intra Hepatic Cholangiocarcinoma Liver Metastasis||Procedure: liver surgery|
a new dimension of the activity expected of physicians is to improve the safety of care on the one hand and the control of health care costs on the other.
key measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.
Internationalwide recent and concordant data suggest that
- quality and security of care, after an initial improvement, are going to stall
- scientific recommendations are rarely validated by an impact analysis and are not applied
- clinical data collected within an administrative framework are unreliable and too generalist
- the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery|
|Actual Study Start Date :||September 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure
Procedure: liver surgery
this intervention type includes hepatectomies; wedge; segmentectomies etc...
- overall postoperative length of stay [ Time Frame: during the 3 months after the surgery ]
the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.
This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.
- peroperative outcomes [ Time Frame: during the surgical procedure ]the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention
- postoperative outcomes [ Time Frame: after the surgery until postoperative month 3 ]the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...
- construct of pronostic models [ Time Frame: after the postoperative month 3 ]the construct of pronostic models include variables that affect the length of stay; morbidity and mortality
- evaluation of PMSI indicators [ Time Frame: after the postoperative month 3 ]this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results
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): NCT01715402
|Amiens North Hospital|
|Beaujon University Hospital|
|Lille Regional Hospital|
|Paoli calmette institute|
|Saint Antoine Hospital|
|Gustave Roussy institute|
|Paul Brousse Hospital|
|Principal Investigator:||Olivier FARGES, MD, phD||Beaujon University Hospital|