NCT04180735

Brief Summary

Liver transplantation enhances the prognosis of patients with cirrhoses or hepatocellular carcinoma. However some patients develop intestinal perforations for which the prognosis is poor. The aim of the study is to evaluate the risk factors of intestinal perforations using a retrospective study scheme.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
Last Updated

November 29, 2019

Status Verified

August 1, 2019

Enrollment Period

1 day

First QC Date

August 6, 2019

Last Update Submit

November 25, 2019

Conditions

Keywords

Risk FactorsSurvival

Outcome Measures

Primary Outcomes (3)

  • Evaluate the total length of stay

    Evaluate the total length of stay

    1 month

  • Evaluate the total length of stay

    Evaluate the total length of stay

    3 months

  • Evaluate the total length of stay

    Evaluate the total length of stay

    6 months.

Secondary Outcomes (5)

  • Evaluate the occurrence of death

    1 month, 3 months, 6 months.

  • Evaluate the total number of complications

    1 month, 3 months, 6 months.

  • Evaluate the number of perforations

    1 month, 3 months, 6 months.

  • Evaluate the quality of life

    1 month, 3 months, 6 months.

  • Evaluate the occurrence of an acute or chronic rejection

    1 month, 3 months, 6 months.

Study Arms (2)

Perforation

Perforation

Procedure: Liver transplantation

No perforation

No perforation

Procedure: Liver transplantation

Interventions

Liver transplantation

No perforationPerforation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019

You may qualify if:

  • Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019
  • for the group Perforation: patients having during the follow-up a complication such as intestinal perforation. The complete list uses the ICD-10 codes for intestinal perforation, esophageal perforation, duodenal perforation etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Intestinal PerforationDigestive System FistulaIntestinal Fistula

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Officials

  • Fabrizio PANARO, PhD

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

November 29, 2019

Study Start

September 30, 2019

Primary Completion

October 1, 2019

Study Completion

October 30, 2019

Last Updated

November 29, 2019

Record last verified: 2019-08

Locations