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
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring hepatic hydrothorax, thoracoscopic surgery, diaphragmatic defect
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.
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
NCT ID
NCT02508688
First Posted
July 21, 2015
Last Updated
July 27, 2015
Sponsor
National Taiwan University Hospital
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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