Interest of an Early Rehabilitation Program in Liver Transplant Surgery

Liver Transplantation Clinical Trial

— RAC-TH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976765
• Other study ID #: 35RC18_9723_RAC-TH
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: August 11, 2020

Study information

• Verified date: April 2021
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Monocentric, prospective study to evaluate 10 liver transplanted patients

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with an hospital discharge at day 7		Day 7
Secondary	Number of patients readmission in the first month		Month 1
Secondary	Number of days of hospitalization during the first month (post-surgery and prehospitalization)		Month 1
Secondary	Number of death in the first month		Month 1
Secondary	Satisfaction of the patient in the first month		Month 1
Secondary	Number of surgery complications according to Dindo and Clavien classification during the first month		Month 1