Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital (Perfogreffe)

November 25, 2019 updated by: University Hospital, Montpellier

Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Previous studies have shown a possible implication of drugs or medical history or intraoperative complications. The investigators aim to describe the other possible risk factors (such as portal vein clampage) and the type of surgery done after the diagnosis and its impact on survival as well.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UH Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Perforation
Procedure: Liver transplantation
Liver transplantation
No perforation
Procedure: Liver transplantation
Liver transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the total length of stay
Time Frame: 1 month
Evaluate the total length of stay
1 month
Evaluate the total length of stay
Time Frame: 3 months
Evaluate the total length of stay
3 months
Evaluate the total length of stay
Time Frame: 6 months.
Evaluate the total length of stay
6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the occurrence of death
Time Frame: 1 month, 3 months, 6 months.
Evaluate the occurrence of death
1 month, 3 months, 6 months.
Evaluate the total number of complications
Time Frame: 1 month, 3 months, 6 months.
Evaluate the total number of complications
1 month, 3 months, 6 months.
Evaluate the number of perforations
Time Frame: 1 month, 3 months, 6 months.
Evaluate the number of perforations
1 month, 3 months, 6 months.
Evaluate the quality of life
Time Frame: 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
Time Frame: 1 month, 3 months, 6 months.
Evaluate the occurrence of an acute or chronic rejection
1 month, 3 months, 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Université Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2019

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 30, 2019

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

November 25, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0362

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on Liver transplantation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe