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

Completed

• Conditions: Digestive System Fistula; Liver Transplantation; Intestinal Perforation; Intestinal Fistula
• Interventions: Procedure: Liver transplantation

• Registration Number: NCT04180735
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-06
• Study Start: 2019-09-30
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-30
• Study First Submitted QC: 2019-11-25
• Last Update Submitted: 2019-11-25
• Study First Posted: 2019-11-29
• Last Update Posted: 2019-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No perforation	Liver transplantation	No perforation
Perforation	Liver transplantation	Perforation

Primary Outcome Measures

Name	Time	Method
Evaluate the total length of stay	6 months.	Evaluate the total length of stay

Secondary Outcome Measures

Name	Time	Method
Evaluate the number of perforations	1 month, 3 months, 6 months.	Evaluate the number of perforations
Evaluate the occurrence of an acute or chronic rejection	1 month, 3 months, 6 months.	Evaluate the occurrence of an acute or chronic rejection
Evaluate the occurrence of death	1 month, 3 months, 6 months.	Evaluate the occurrence of death
Evaluate the quality of life	1 month, 3 months, 6 months.	Evaluate the quality of life
Evaluate the total number of complications	1 month, 3 months, 6 months.	Evaluate the total number of complications

Trial Locations

Locations (1)

Uh Montpellier; 🇫🇷 Montpellier, France