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

Liver Transplantation Clinical Trial

— Perfogreffe  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180735
• Other study ID #: RECHMPL19_0362
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Digestive System Fistula
• Fistula
• Intestinal Fistula
• Intestinal Perforation
• Liver Transplantation

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.