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OpenTrials
Completed

NCT Number: NCT03976765

Interest of an Early Rehabilitation Program in Liver Transplant Surgery

Monocentric, prospective study to evaluate 10 liver transplanted patients

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation program

Other

The patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria

Primary outcomes

  1. Number of patients with an hospital discharge at day 7

    Time frame: Day 7

Secondary outcomes

  1. Number of patients readmission in the first month

    Time frame: Month 1

  2. Number of days of hospitalization during the first month (post-surgery and prehospitalization)

    Time frame: Month 1

  3. Number of death in the first month

    Time frame: Month 1

  4. Satisfaction of the patient in the first month

    Time frame: Month 1

  5. Number of surgery complications according to Dindo and Clavien classification during the first month

    Time frame: Month 1

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: RAC-TH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 6, 2019
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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