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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01715402
Other study ID # AOM 11060
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 22, 2012
Last updated February 3, 2017
Start date September 2012
Est. completion date December 2018

Study information

Verified date February 2017
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3000
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
liver surgery
this intervention type includes hepatectomies; wedge; segmentectomies etc...

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall postoperative length of stay 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 peroperative outcomes the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention during the surgical procedure
Secondary postoperative outcomes the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding... after the surgery until postoperative month 3
Secondary construct of pronostic models the construct of pronostic models include variables that affect the length of stay; morbidity and mortality after the postoperative month 3
Secondary evaluation of PMSI indicators this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results after the postoperative month 3
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