Optimization of Health Expenditure in Liver Surgery
This study is enrolling participants by invitation only.
Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01715402
First received: October 22, 2012
Last updated: July 28, 2015
Last verified: July 2015
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Purpose
The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.
| Condition | Intervention |
|---|---|
|
Hepatocellular Carcinoma Hilar Cholangiocarcinoma Intra Hepatic Cholangiocarcinoma Liver Metastasis |
Procedure: liver surgery |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
cholangiocarcinoma
Genetic and Rare Diseases Information Center resources:
Liver Cancer
Intrahepatic Cholangiocarcinoma
Klatskin Tumor
U.S. FDA Resources
Further study details as provided by Centre Hospitalier Universitaire, Amiens:
Primary Outcome Measures:
- overall postoperative length of stay [ Time Frame: during the 3 months after the surgery ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- peroperative outcomes [ Time Frame: during the surgical procedure ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results
| Estimated Enrollment: | 3000 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
operated patients
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...
|
Detailed Description:
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715402
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715402
Locations
| 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 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Olivier FARGES, MD, phD | Beaujon University Hospital |
More Information
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT01715402 History of Changes |
| Other Study ID Numbers: | AOM 11060 |
| Study First Received: | October 22, 2012 |
| Last Updated: | July 28, 2015 |
| Health Authority: | France: Commission nationale de l'informatique et des libertés France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Centre Hospitalier Universitaire, Amiens:
|
liver tumor carcinoma cholangiocarcinoma metastasis |
Additional relevant MeSH terms:
|
Carcinoma, Hepatocellular Neoplasm Metastasis Cholangiocarcinoma Klatskin Tumor Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Neoplastic Processes Pathologic Processes Liver Extracts Hematinics |
ClinicalTrials.gov processed this record on September 27, 2016