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Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thoracoscopic diaphragmatic repair
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring hepatic hydrothorax, thoracoscopic surgery, diaphragmatic defect

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    thoracoscopic mesh repair group

    Arm Description

    63 patients with refractory HH (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair were included in this study.

    Outcomes

    Primary Outcome Measures

    one-month mortality
    one-month mortality after thoracoscopic mesh repair
    three-month mortality
    three-month mortality after thoracoscopic mesh repair

    Secondary Outcome Measures

    recurrence of hepatic hydrothorax
    recurrence of hepatic hydrothorax after thoracoscopic mesh repair

    Full Information

    First Posted
    July 21, 2015
    Last Updated
    July 27, 2015
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02508688
    Brief Title
    Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax
    Official Title
    Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax: 10 Years' Experience From a Single Large-volume Center
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Cirrhosis
    Keywords
    hepatic hydrothorax, thoracoscopic surgery, diaphragmatic defect

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    thoracoscopic mesh repair group
    Arm Type
    Experimental
    Arm Description
    63 patients with refractory HH (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair were included in this study.
    Intervention Type
    Procedure
    Intervention Name(s)
    thoracoscopic diaphragmatic repair
    Intervention Description
    patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair
    Primary Outcome Measure Information:
    Title
    one-month mortality
    Description
    one-month mortality after thoracoscopic mesh repair
    Time Frame
    one month
    Title
    three-month mortality
    Description
    three-month mortality after thoracoscopic mesh repair
    Time Frame
    three month
    Secondary Outcome Measure Information:
    Title
    recurrence of hepatic hydrothorax
    Description
    recurrence of hepatic hydrothorax after thoracoscopic mesh repair
    Time Frame
    20.5 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pei-Ming Huang, MD, PhD
    Organizational Affiliation
    Department of Surgery, National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/26088408
    Description
    Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/25304302
    Description
    Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resections
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/25811649
    Description
    Hepatorenal Disorders
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/24811830
    Description
    Management of refractory hepatic hydrothorax
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23085762
    Description
    Hepatic hydrothorax
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/23312983
    Description
    Percutaneous transhepatic biliary drainage complicated with hepatic hydrothorax
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/19660259
    Description
    Color Doppler ultrasonography in detecting transdiaphragmatic flow of hepatic hydrothorax: correlation with thoracoscopic findings
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/16485189
    Description
    Thoracoscopic diaphragmatic repair for refractory hepatic hydrothorax: application of pleural flap and mesh onlay reinforcement
    URL
    http://www.ncbi.nlm.nih.gov/pubmed/15999054
    Description
    The morphology of diaphragmatic defects in hepatic hydrothorax: thoracoscopic finding

    Learn more about this trial

    Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

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