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

Minimally Invasive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04718272
• Other study ID #: CDTM UNION
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2021
• Source: Fujian Medical University Union Hospital
• Contact: Guobing Xu, MD
• Phone: 15880005394
• Email: 15880005394[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chest Tubes
• Minimally Invasive Surgery
• Pneumonectomy

Intervention

Procedure:
• thoracic 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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative complications	The incidence of complications within 30 days after surgery in each arm	within 30 days after surgery
Secondary	Incidence of subcutaneous emphysema after operation	The incidence of subcutaneous emphysema after operation in each arm	within 30 days after surgery
Secondary	Incidence of postoperative pneumothorax	The incidence of postoperative pneumothorax in each arm	within 30 days after surgery