Clinical trial NCT01715402: Optimization of Health Expenditure in Liver Surgery
Official title: Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Hilar Cholangiocarcinoma
Intra Hepatic Cholangiocarcinoma
Liver Metastasis
Keywords: liver tumor
carcinoma
cholangiocarcinoma
metastasis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2012-10-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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 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

Primary outcomes:
measure: overall postoperative length of stay
timeFrame: during the 3 months after the surgery
Secondary outcomes:
measure: peroperative outcomes
timeFrame: during the surgical procedure
measure: postoperative outcomes
timeFrame: after the surgery until postoperative month 3
measure: construct of pronostic models
timeFrame: after the postoperative month 3
measure: evaluation of PMSI indicators
timeFrame: after the postoperative month 3
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens North Hospital
city: Bordeaux
country: France
facility: Bordeaux Hospital
city: Clichy
country: France
facility: Beaujon University Hospital
city: Lille
country: France
facility: Lille Regional Hospital
city: Lyon
country: France
facility: Lyon Hospital
city: Marseille
country: France
facility: Marseille Hospital
city: Marseille
country: France
facility: Paoli calmette institute
city: Paris
country: France
facility: Saint Antoine Hospital
city: Strasbourg
country: France
facility: Strasbourg hospital
city: Villejuif
country: France
facility: Gustave Roussy institute
city: Villejuif
country: France
facility: Paul Brousse Hospital
Study officials:
affiliation: Beaujon University Hospital
name: Olivier FARGES, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Gregoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.