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Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy

Safety and Feasibility of the Application of Thoracic Puncture Tube VS Combination of Puncture Tube and Silicone Tube After Uniportal VATS Pulmonary Lobectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04718272
Enrollment
100
Registered
2021-01-22
Start date
2021-01-25
Completion date
2024-04-30
Last updated
2021-05-11

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

Conditions

Chest Tubes, Minimally Invasive Surgery, Pneumonectomy

Keywords

Chest Tubes, Pneumonectomy, Minimally Invasive Surgery

Brief summary

There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.

Detailed description

This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery)lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.

Interventions

PROCEDUREthoracic drainage management

After uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group.

Sponsors

Fujian Medical University Union Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Age and gender: 18-70 years old, male and female unlimited; 2. Cardiopulmonary function can tolerate operation; 3. Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed; 4. No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position. 5. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..

Exclusion criteria

1. Patients with a severe emphysema or pulmonary bullae; 2. Patients with a history of chemotherapy or chemo-radiotherapy; 3. Patients with a history of chest surgery; 4. Extensive thoracic adhesion ; 5. A history of serious mental illness; 6. Patients with other conditions considered by the researcher should not participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative complicationswithin 30 days after surgeryThe incidence of complications within 30 days after surgery in each arm

Secondary

MeasureTime frameDescription
Incidence of subcutaneous emphysema after operationwithin 30 days after surgeryThe incidence of subcutaneous emphysema after operation in each arm
Incidence of postoperative pneumothoraxwithin 30 days after surgeryThe incidence of postoperative pneumothorax in each arm

Countries

China

Contacts

Primary ContactGuobing Xu, MD
15880005394@163.com15880005394
Backup ContactChun Chen, MD
chenchun0209@163.com13365910325

Outcome results

None listed

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