Optimization of Health Expenditure in Liver Surgery

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Unknown status
CT.gov ID
NCT01715402
Collaborator
Assistance Publique - Hôpitaux de Paris (Other)
3,000
11
75
272.7
3.6

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Procedure: liver surgery

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 Design

Study Type:
Observational
Anticipated 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 :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm 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...

Outcome Measures

Primary Outcome Measures

  1. overall postoperative length of stay [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.

Secondary Outcome Measures

  1. peroperative outcomes [during the surgical procedure]

    the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention

  2. postoperative outcomes [after the surgery until postoperative month 3]

    the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...

  3. construct of pronostic models [after the postoperative month 3]

    the construct of pronostic models include variables that affect the length of stay; morbidity and mortality

  4. evaluation of PMSI indicators [after the postoperative month 3]

    this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Amiens North Hospital Amiens France
2 Bordeaux Hospital Bordeaux France
3 Beaujon University Hospital Clichy France
4 Lille Regional Hospital Lille France
5 Lyon Hospital Lyon France
6 Marseille Hospital Marseille France
7 Paoli calmette institute Marseille France
8 Saint Antoine Hospital Paris France
9 Strasbourg hospital Strasbourg France
10 Gustave Roussy institute Villejuif France
11 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01715402
Other Study ID Numbers:
  • AOM 11060
First Posted:
Oct 29, 2012
Last Update Posted:
Feb 6, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 6, 2017