Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes
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|ClinicalTrials.gov Identifier: NCT03743389|
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Information provided by (Responsible Party):
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.
|Condition or disease||Intervention/treatment||Phase|
|Mediastinal Nodes||Device: 12G pigtail catheter Device: 16F chest tube||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Application Study of 12G Pigtail Catheter Used for Post-operative Drainage After Thoracoscopic Surgery for Mediastinal Nodes|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||October 30, 2019|
|Estimated Study Completion Date :||November 30, 2019|
|Experimental: 12G pigtail catheter||
Device: 12G pigtail catheter
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.
|Active Comparator: 16F chest tube||
Device: 16F chest tube
16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.
Primary Outcome Measures :
- total drainage volume [ Time Frame: 1 month ]
- tube duration [ Time Frame: 1 month ]
Secondary Outcome Measures :
- post-operative pain [ Time Frame: 3 days after operation ]assessed via the "Visual Analogue Scale" (VAS) which ranging from 0 (no pain) to 10 (worst imaginable pain).
- rate of subcutaneous emphysema [ Time Frame: 1 month ]
- infection rate of incision [ Time Frame: 1 month ]
- length of hospital stay after surgery [ Time Frame: 1 month ]
- rate of chest tube re-insertion or thoracocentesis [ Time Frame: 1 month ]
- satisfaction of the incision after healing [ Time Frame: 1 month ]Patients would be asked if they are satified with the appearence of the healed incision at the one-month follow-up evalution.
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