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OpenTrials
Completed

NCT Number: NCT02508688

Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

The management of refractory hepatic hydrothorax is challenging and usually unsuccessful. The study will discuss the perioperative treatment, effectiveness, and morphology of diaphragmatic defects of hepatic hydrothorax in thoracoscopic mesh repair. Risk factors associated with increased three-month mortality in these critically ill patients will be studied.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Objective The objective was to analyze the outcomes of thoracoscopic mesh repair for hepatic hydrothorax (HH) at the institution of the investigators during the past 10 years.

Methods A total of 63 patients with refractory HH, who underwent thoracoscopic mesh onlay reinforcement to repair diaphragmatic defects from January 2005 to December 2014, were included in the study. Mesh covering alone was used in 47 patients and mesh with suturing was used in 16 patients. Patient demographics, Child-Pugh class, and model for end-stage liver disease (MELD) score were evaluated to predict morbidity and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics)

Exclusion criteria

  • Patients with systemic bacteremia, positive culture of bacteria of pleural effusion or ascites were excluded from the study because of potential mesh contamination.

Treatment and study plan

thoracoscopic diaphragmatic repair

Procedure

patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair

Primary outcomes

  1. one-month mortality

    Time frame: one month

    one-month mortality after thoracoscopic mesh repair

  2. three-month mortality

    Time frame: three month

    three-month mortality after thoracoscopic mesh repair

Secondary outcomes

  1. recurrence of hepatic hydrothorax

    Time frame: 20.5 months

    recurrence of hepatic hydrothorax after thoracoscopic mesh repair

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center

Important dates

Study start
2005
Primary completion
2014
Study completion
2015
First posted
Jul 27, 2015
Registry last updated
Jul 29, 2015

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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