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

T

Tongji Hospital

Status

Unknown

Conditions

Mediastinal Nodes

Treatments

Device: 12G pigtail catheter
Device: 16F chest tube

Study type

Interventional

Funder types

Other

Identifiers

NCT03743389
TJTS-CT001

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

12G pigtail catheter
Experimental group
Treatment:
Device: 12G pigtail catheter
16F chest tube
Active Comparator group
Treatment:
Device: 16F chest tube

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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