Clinical trial NCT04180735: Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital
Official title: Intestinal Perforation in Patients Receiving an Orthtopic Liver Transplantation in the Montpellier University Hospital: a Retrospective and Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Intestinal Perforation
Digestive System Fistula
Intestinal Fistula
Keywords: Risk Factors
Survival
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2019-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having received an orthotopic liver transplantation in the Montpellier University Hospital from 2014 to 2019

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the total length of stay
timeFrame: 1 month
measure: Evaluate the total length of stay
timeFrame: 3 months
measure: Evaluate the total length of stay
timeFrame: 6 months.
Secondary outcomes:
measure: Evaluate the occurrence of death
timeFrame: 1 month, 3 months, 6 months.
measure: Evaluate the total number of complications
timeFrame: 1 month, 3 months, 6 months.
measure: Evaluate the number of perforations
timeFrame: 1 month, 3 months, 6 months.
measure: Evaluate the quality of life
timeFrame: 1 month, 3 months, 6 months.
measure: Evaluate the occurrence of an acute or chronic rejection
timeFrame: 1 month, 3 months, 6 months.
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Fabrizio PANARO, PhD
role: STUDY_DIRECTOR
References: