Interest of an Early Rehabilitation Program in Liver Transplant Surgery

NCT ID: NCT03976765

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-17

Study Completion Date

2020-08-11

Brief Summary

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Monocentric, prospective study to evaluate 10 liver transplanted patients

Detailed Description

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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.

Conditions

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Liver Transplantation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Hospital discharge at day 7

Rehabilitation program

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Rennes

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC18_9723_RAC-TH

Identifier Type: -

Identifier Source: org_study_id

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