Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes

Study Overview
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Brief Summary
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Pigtail catheter(PC) has been used for thoracic drainage in the patients with pneumothorax or traumatic hemothorax/hemopneumothorax, and some study indicated that PC could obtain similar outcomes when comparing with chest tube(CT). Although PC could drain air and fluid out from pleural cavity and also help pulmonary re-expanding, rare reports are available to thoracic post-operative management. Uniportal video-assisted thoracoscopic surgery(VATS) has been widely applied in many medical center in recent years, most of mediastinal nodes could be resected under uniportal-VATS. This study aims to further study the application of 12G PC during post-operative management and comparing the validity and safety between PC(12G) and CT(16F) after uniportal-VATS for mediastinal nodes resection.

Official Title
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Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes

Conditions
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Mediastinal Nodes

Intervention / Treatment
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* Device: 12G pigtail catheter
* Device: 16F chest tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 80 years of age. Diagnosed with potentially resectable mediastinal mass. With indication for uniportal-VATS. For whom informed consent will be obtained before the study. Exclusion Criteria: Previous thoracic surgery at the same side. Have to receive open surgery although uniportal-VATS is planned. Pregnancy. Refuse to sigh the consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12G pigtail catheter<br> | Device: 12G pigtail catheter<br>* 12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube.<br>|
| Active Comparator: 16F chest tube<br> | Device: 16F chest tube<br>* 16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total drainage volume |  | 1 month | 
| tube duration |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-operative pain | assessed via the Visual Analogue Scale (VAS) which ranging from 0 (no pain) to 10 (worst imaginable pain). | 3 days after operation | 
| rate of subcutaneous emphysema |  | 1 month | 
| infection rate of incision |  | 1 month | 
| length of hospital stay after surgery |  | 1 month | 
| rate of chest tube re-insertion or thoracocentesis |  | 1 month | 
| satisfaction of the incision after healing | Patients would be asked if they are satified with the appearence of the healed incision at the one-month follow-up evalution. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uniportal video-assisted thoracoscopic surgery, mediastinal nodes, chest drainage, pigtail catheter