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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
Sponsor:
Information provided by (Responsible Party):
Tongji Hospital

Brief Summary:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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 :
  1. total drainage volume [ Time Frame: 1 month ]
  2. tube duration [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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).

  2. rate of subcutaneous emphysema [ Time Frame: 1 month ]
  3. infection rate of incision [ Time Frame: 1 month ]
  4. length of hospital stay after surgery [ Time Frame: 1 month ]
  5. rate of chest tube re-insertion or thoracocentesis [ Time Frame: 1 month ]
  6. 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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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 and 80 years of age.
  2. Diagnosed with potentially resectable mediastinal mass.
  3. With indication for uniportal-VATS.
  4. For whom informed consent will be obtained before the study.

Exclusion Criteria:

  1. Previous thoracic surgery at the same side.
  2. Have to receive open surgery although uniportal-VATS is planned.
  3. Pregnancy.
  4. Refuse to sigh the consent
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Responsible Party: Tongji Hospital
ClinicalTrials.gov Identifier: NCT03743389    
Other Study ID Numbers: TJTS-CT001
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tongji Hospital:
uniportal video-assisted thoracoscopic surgery
mediastinal nodes
chest drainage
pigtail catheter