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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04180735
Other study ID # RECHMPL19_0362
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2019
Est. completion date October 30, 2019

Study information

Verified date August 2019
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 30, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Procedure:
Liver transplantation
Liver transplantation

Locations

Country Name City State
France Uh Montpellier Montpellier

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Montpellier Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the total length of stay Evaluate the total length of stay 1 month
Primary Evaluate the total length of stay Evaluate the total length of stay 3 months
Primary Evaluate the total length of stay Evaluate the total length of stay 6 months.
Secondary Evaluate the occurrence of death Evaluate the occurrence of death 1 month, 3 months, 6 months.
Secondary Evaluate the total number of complications Evaluate the total number of complications 1 month, 3 months, 6 months.
Secondary Evaluate the number of perforations Evaluate the number of perforations 1 month, 3 months, 6 months.
Secondary Evaluate the quality of life Evaluate the quality of life 1 month, 3 months, 6 months.
Secondary Evaluate the occurrence of an acute or chronic rejection Evaluate the occurrence of an acute or chronic rejection 1 month, 3 months, 6 months.
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