Interest of an Early Rehabilitation Program in Liver Transplant Surgery

Completed

• Conditions: Liver Transplantation
• Interventions: Other: Rehabilitation program

• Registration Number: NCT03976765
• Lead Sponsor: Rennes University Hospital

Brief Summary

Monocentric, prospective study to evaluate 10 liver transplanted patients

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 Timeline

• Study Start: 2018-12-17
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospital discharge at day 7	Rehabilitation program	-

Primary Outcome Measures

Name	Time	Method
Number of patients with an hospital discharge at day 7	Day 7

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Rennes; 🇫🇷 Rennes, France