Optimization of Health Expenditure in Liver Surgery

February 3, 2017 updated by: Centre Hospitalier Universitaire, Amiens

Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • Amiens North Hospital
      • Bordeaux, France
        • Bordeaux Hospital
      • Clichy, France
        • Beaujon University Hospital
      • Lille, France
        • Lille Regional Hospital
      • Lyon, France
        • Lyon Hospital
      • Marseille, France
        • Marseille Hospital
      • Marseille, France
        • Paoli Calmette Institute
      • Paris, France
        • Saint Antoine Hospital
      • Strasbourg, France
        • Strasbourg Hospital
      • Villejuif, France
        • PAUL BROUSSE HOSPITAL
      • Villejuif, France
        • Gustave Roussy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
during the 3 months after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during the surgical procedure
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...
after the surgery until postoperative month 3
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
after the postoperative month 3
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
after the postoperative month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Olivier FARGES, MD, phD, Beaujon University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 22, 2012

First Submitted That Met QC Criteria

October 24, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Estimate)

February 6, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM 11060

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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