Optimization of Health Expenditure in Liver Surgery
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| ClinicalTrials.gov Identifier: NCT01715402 |
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Recruitment Status
:
Enrolling by invitation
First Posted
: October 29, 2012
Last Update Posted
: February 6, 2017
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| 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 |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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operated patients
this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure
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Procedure: liver surgery
this intervention type includes hepatectomies; wedge; segmentectomies etc...
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- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
the population corresponds to patients operated in one of the thirteen hospitals.
These hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population
Inclusion Criteria:
- elective liver surgery
- older than 18
- agreed to participate
- surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database
Exclusion Criteria:
- emergency surgery
- refused to participate
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
| France | |
| Amiens North Hospital | |
| Amiens, France | |
| Bordeaux Hospital | |
| Bordeaux, France | |
| Beaujon University Hospital | |
| Clichy, France | |
| Lille Regional Hospital | |
| Lille, France | |
| Lyon Hospital | |
| Lyon, France | |
| Marseille Hospital | |
| Marseille, France | |
| Paoli calmette institute | |
| Marseille, France | |
| Saint Antoine Hospital | |
| Paris, France | |
| Strasbourg hospital | |
| Strasbourg, France | |
| Gustave Roussy institute | |
| Villejuif, France | |
| Paul Brousse Hospital | |
| Villejuif, France | |
| Principal Investigator: | Olivier FARGES, MD, phD | Beaujon University Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT01715402 History of Changes |
| Other Study ID Numbers: |
AOM 11060 |
| First Posted: | October 29, 2012 Key Record Dates |
| Last Update Posted: | February 6, 2017 |
| Last Verified: | February 2017 |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
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liver tumor carcinoma cholangiocarcinoma metastasis |
Additional relevant MeSH terms:
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Neoplasm Metastasis Carcinoma, Hepatocellular Cholangiocarcinoma Klatskin Tumor Neoplastic Processes Neoplasms Pathologic Processes Adenocarcinoma Carcinoma |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Liver Extracts Hematinics |