Interest of an Early Rehabilitation Program in Liver Tran... | NCT03976765

Studies
Interest of an Early Rehabilitation Program in Liver Transplant Surgery

NCT03976765

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 15, 2021Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Liver Transplantation

Interventions

Rehabilitation program

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2018Actual

Primary Completion Date

Aug 11, 2020Actual

Completion Date

Aug 11, 2020Actual

First Submitted Date

Jun 4, 2019

First Submission Date that Met QC Criteria

Jun 4, 2019

First Posted Date

Jun 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2021

Last Update Posted Date

Apr 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hospital discharge at day 7			Other: Rehabilitation program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Liver transplant patients

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35033	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012046	Rehabilitation

Ancestor Terms

ID	Term
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided