Optimization of Health Expenditure in Liver Surgery

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01715402
• Other study ID #: AOM 11060
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Hepatocellular Carcinoma
• Hilar Cholangiocarcinoma
• Intra Hepatic Cholangiocarcinoma
• Klatskin Tumor
• Liver Metastasis
• Neoplasm Metastasis

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