NCT01715402

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Longer than P75 for all trials

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

5.3 years

First QC Date

October 22, 2012

Last Update Submit

February 3, 2017

Conditions

Keywords

liver tumorcarcinomacholangiocarcinomametastasis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • peroperative outcomes

    during the surgical procedure

  • postoperative outcomes

    after the surgery until postoperative month 3

  • construct of pronostic models

    after the postoperative month 3

  • evaluation of PMSI indicators

    after the postoperative month 3

Study Arms (1)

operated patients

this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure

Procedure: liver surgery

Interventions

liver surgeryPROCEDURE

this intervention type includes hepatectomies; wedge; segmentectomies etc...

operated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • emergency surgery
  • refused to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Amiens North Hospital

Amiens, France

Location

Bordeaux Hospital

Bordeaux, France

Location

Beaujon University Hospital

Clichy, France

Location

Lille Regional Hospital

Lille, France

Location

Lyon Hospital

Lyon, France

Location

Marseille Hospital

Marseille, France

Location

Paoli calmette institute

Marseille, France

Location

Saint Antoine Hospital

Paris, France

Location

Strasbourg hospital

Strasbourg, France

Location

Gustave Roussy institute

Villejuif, France

Location

Paul Brousse Hospital

Villejuif, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Carcinoma, HepatocellularKlatskin TumorCarcinomaCholangiocarcinomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier FARGES, MD, phD

    Beaujon University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 29, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

February 6, 2017

Record last verified: 2017-02

Locations