Optimization of Health Expenditure in Liver Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Centre Hospitalier Universitaire, Amiens
Sponsor:
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: November 26, 2013
Last verified: November 2013
  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:


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 2014
Estimated Primary Completion Date: December 2014 (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
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

Contacts
Contact: olivier farges, MD, phD Olivier.farges@bjn.aphp.fr

Locations
France
Amiens North Hospital Recruiting
Amiens, France
Contact: jean marc regimbeau, MD, PhD    +33 3 22 66 83 00    regimbeau.jean-marc@chu-amiens.fr   
Bordeaux Hospital Recruiting
Bordeaux, France
Contact: christophe laurent, MD, PhD    +33 5 56 79 56 79    christophe.laurent@chu-bordeaux.fr   
Beaujon University Hospital Recruiting
Clichy, France
Contact: olivier farges, MD, PhD    +33 1 40 87 50 00    Olivier.farges@bjn.aphp.fr   
Lille Regional Hospital Recruiting
Lille, France
Contact: pruvot francois rené, MD, PhD    +33 3 20 44 59 62    francois-rene.pruvot@chru-lille.fr   
Lyon Hospital Recruiting
Lyon, France
Contact: mustapha adham, MD, PhD    +33 4 72 11 62 61    mustapha.adham@chu-lyon.fr   
Lyon Hospital Recruiting
Lyon, France
Contact: christian ducerf, MD, PhD    +33472071631    christian.ducerf@chu-lyon.fr   
Marseille Hospital Recruiting
Marseille, France
Contact: yves patrice letreut, MD, PhD    +33 4 91 38 38 58    yves-patrice.letreut@ap-hm.fr   
Paoli calmette institute Recruiting
Marseille, France
Contact: jean robert delpero, MD, PhD    +33 4-91-22-36-60    delperojr@marseille.fnclcc.fr   
Saint Antoine Hospital Recruiting
Paris, France
Contact: olivier soubrane, MD, PhD    +33 1 71 97 01 81    olivier.soubrane@sat.aphp.fr   
Saint Antoine Hospital Recruiting
Paris, France
Contact: francois paye, MD, PhD    + 33 1 49 28 25 33    francois.paye@sat.aphp.fr   
Strasbourg hospital Recruiting
Strasbourg, France
Contact: philippe bachellier, MD, PhD    +33 3.88.12.71.71    philippe.bachellier@chru-strasbourg.fr   
Gustave Roussy institute Recruiting
Villejuif, France
Contact: dominique elias, MD, PhD    +33 1 42 11 42 11    elias@igr.fr   
Sub-Investigator: diane goere, MD, PhD         
Paul Brousse Hospital Recruiting
Villejuif, France
Contact: eric vibert, MD, PhD    + 33 1 45 59 34 11    eric.vibert@pbr.aphp.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

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: November 26, 2013
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
Carcinoma, Hepatocellular
Cholangiocarcinoma
Klatskin's Tumor
Liver Neoplasms
Neoplasm Metastasis
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014