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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03743389
Enrollment
80
Registered
2018-11-16
Start date
2018-12-01
Completion date
2019-11-30
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal Nodes

Keywords

uniportal video-assisted thoracoscopic surgery, mediastinal nodes, chest drainage, pigtail catheter

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.

Interventions

DEVICE12G 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.

DEVICE16F 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.

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
total drainage volume1 month
tube duration1 month

Secondary

MeasureTime frameDescription
infection rate of incision1 month
length of hospital stay after surgery1 month
post-operative pain3 days after operationassessed via the Visual Analogue Scale (VAS) which ranging from 0 (no pain) to 10 (worst imaginable pain).
satisfaction of the incision after healing1 monthPatients 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 thoracocentesis1 month
rate of subcutaneous emphysema1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026