Interest of an Early Rehabilitation Program in Liver Transplant Surgery (RAC-TH)

April 14, 2021 updated by: Rennes University Hospital

Early Rehabilitation Program in Liver Transplant Surgery: Hospital Discharge at Day 7 in a Targeted Population

Monocentric, prospective study to evaluate 10 liver transplanted patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The improvement of perioperative technics and the prevention of complications with immunosuppression allowed for the development with success of liver transplant. 1322 liver transplants occurred in 2016 in France to 806 in 2000. Centre Hospitalier Universitaire (CHU) of Rennes became a reference with 122 liver transplants in 2016 being the second liver transplant center in France.

Early rehabilitation concept is a multidisciplinary approach (surgical, anesthetic…) that aims to reduce the length of hospital stay and peri operative morbidity/mortality. These programs have first been developed in colorectal surgery before extending to complicated surgery like cephalic duodeno-pancreatectomy or hepatectomy. There are poor data in the literature on early rehabilitation program in liver transplant.

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liver transplant patients

Description

Inclusion Criteria:

  • Patient older than 18 years old
  • First liver transplant
  • Liver transplant alone
  • MELD (Model for End stage Liver Disease) score ≤ 15
  • CHILD-PUGH score ≤ 8 if cirrhosis
  • Body Mass Index < 30 kg/m2
  • No history of transplant nor immunosuppression
  • Absence of ascites nor hydrothorax drain
  • Absence of treatment for diabetes
  • Absence of renal insufficiency (glomerular filtration flow > 60 mL/min)
  • Family help at home

Exclusion Criteria:

  • Cold ischemia time > 8 hours
  • Grafts from type III Maastricht
  • Super urgent liver transplantation
  • Perioperative blood transfusion > 4 packed red blood cells and/or 3 fresh frozen plasma
  • Arterial anastomosis in splenic artery, in aorta or in coeliac artery
  • Bilio-digestive anastomosis
  • Persons deprived of liberty
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital discharge at day 7
Other: Rehabilitation program
The patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients with an hospital discharge at day 7
Time Frame: Day 7
Day 7

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients readmission in the first month
Time Frame: Month 1
Month 1
Number of days of hospitalization during the first month (post-surgery and prehospitalization)
Time Frame: Month 1
Month 1
Number of death in the first month
Time Frame: Month 1
Month 1
Satisfaction of the patient in the first month
Time Frame: Month 1
Month 1
Number of surgery complications according to Dindo and Clavien classification during the first month
Time Frame: Month 1
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2018

Primary Completion (Actual)

August 11, 2020

Study Completion (Actual)

August 11, 2020

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 14, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC18_9723_RAC-TH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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