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

Not Applicable

• Conditions: Chest Tubes; Minimally Invasive Surgery; Pneumonectomy
• Interventions: Procedure: thoracic drainage management

• Registration Number: NCT04718272
• Lead Sponsor: Fujian Medical University Union Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-18
• Study First Submitted QC: 2021-01-18
• Study First Posted: 2021-01-22
• Study Start: 2021-01-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Puncture tube group	thoracic drainage management	After the operation, the traditional traditional silicone tube which placed through the surgical incision was removed in the operating room, and the small puncture tube was retained for thoracic drainage.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	within 30 days after surgery	The incidence of complications within 30 days after surgery in each arm

Secondary Outcome Measures

Name	Time	Method
Incidence of subcutaneous emphysema after operation	within 30 days after surgery	The incidence of subcutaneous emphysema after operation in each arm
Incidence of postoperative pneumothorax	within 30 days after surgery	The incidence of postoperative pneumothorax in each arm

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China