Clinical trial NCT04718272: Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Tubes
Pneumonectomy
Minimally Invasive Surgery
Keywords: Chest Tubes
Pneumonectomy
Minimally Invasive Surgery
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: within 30 days after surgery
Secondary outcomes:
measure: Incidence of subcutaneous emphysema after operation
timeFrame: within 30 days after surgery
measure: Incidence of postoperative pneumothorax
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chun Chen, MD
role: STUDY_DIRECTOR
References: