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

Not Applicable

• Conditions: Mediastinal Nodes
• Interventions: Device: 16F chest tube; Device: 12G pigtail catheter

• Registration Number: NCT03743389
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-09
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16
• Study Start: 2018-12-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
16F chest tube	16F chest tube	-
12G pigtail catheter	12G pigtail catheter	-

Primary Outcome Measures

Name	Time	Method
total drainage volume	1 month
tube duration	1 month

Secondary Outcome Measures

Name	Time	Method
infection rate of incision	1 month
post-operative pain	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	1 month
length of hospital stay after surgery	1 month
satisfaction of the incision after healing	1 month	Patients would be asked if they are satified with the appearence of the healed incision at the one-month follow-up evalution.
rate of chest tube re-insertion or thoracocentesis	1 month