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Completed

NCT Number: NCT04180735

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

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.

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Key information

Conditions

Liver Transplantation Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Intestinal Perforation Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

About this 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. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Transplantation

Procedure

Liver transplantation

Primary outcomes

  1. Evaluate the total length of stay

    Time frame: 1 month

    Evaluate the total length of stay

  2. Evaluate the total length of stay

    Time frame: 3 months

    Evaluate the total length of stay

  3. Evaluate the total length of stay

    Time frame: 6 months.

    Evaluate the total length of stay

Secondary outcomes

  1. Evaluate the occurrence of death

    Time frame: 1 month, 3 months, 6 months.

    Evaluate the occurrence of death

  2. Evaluate the total number of complications

    Time frame: 1 month, 3 months, 6 months.

    Evaluate the total number of complications

  3. Evaluate the number of perforations

    Time frame: 1 month, 3 months, 6 months.

    Evaluate the number of perforations

  4. Evaluate the quality of life

    Time frame: 1 month, 3 months, 6 months.

    Evaluate the quality of life

  5. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Université Montpellier

Registry information

Official study title

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

Acronym: Perfogreffe

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2019
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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