Thoracoscopic Mesh Repair of Diaphragmatic Defects for Hepatic Hydrothorax

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: thoracoscopic diaphragmatic repair

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: thoracoscopic mesh repair group; 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.	Procedure: thoracoscopic diaphragmatic repair; patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
one-month mortality	one-month mortality after thoracoscopic mesh repair	one month
three-month mortality	three-month mortality after thoracoscopic mesh repair	three month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence of hepatic hydrothorax	recurrence of hepatic hydrothorax after thoracoscopic mesh repair	20.5 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-Ming Huang, MD, PhD, Department of Surgery, National Taiwan University Hospital

Publications and helpful links

Helpful Links

• Symptom recovery after thoracic surgery: Measuring patient-reported outcomes with the MD Anderson Symptom Inventory
• Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resections
• Hepatorenal Disorders
• Management of refractory hepatic hydrothorax
• Hepatic hydrothorax
• Percutaneous transhepatic biliary drainage complicated with hepatic hydrothorax
• Color Doppler ultrasonography in detecting transdiaphragmatic flow of hepatic hydrothorax: correlation with thoracoscopic findings
• Thoracoscopic diaphragmatic repair for refractory hepatic hydrothorax: application of pleural flap and mesh onlay reinforcement
• The morphology of diaphragmatic defects in hepatic hydrothorax: thoracoscopic finding

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): June 1, 2015

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (ESTIMATE): July 27, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: thoracoscopic surgery; hepatic hydrothorax; diaphragmatic defect
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Pleural Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Hydrothorax
• Other Study ID Numbers: 201506012RIND