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

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.

Study Overview

• Status: Recruiting
• Conditions: Chest Tubes; Minimally Invasive Surgery; Pneumonectomy
• Intervention / Treatment: Procedure: thoracic drainage management

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guobing Xu, MD; Phone Number: 15880005394; Email: 15880005394@163.com
• Study Contact Backup: Name: Chun Chen, MD; Phone Number: 13365910325; Email: chenchun0209@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Guobing Xu, MD; Phone Number: 15880005394; Email: 15880005394@163.com
      • Contact: Chun Chen, MD; Phone Number: 13365910325; Email: chenchun0209@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Puncture tube group; 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.	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.
No Intervention: Traditional tubes group; Routine thoracic drainage management measures were adopted, that is, both of the small puncture tube and traditional silicone tube were retained after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative complications	The incidence of complications within 30 days after surgery in each arm	within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of subcutaneous emphysema after operation	The incidence of subcutaneous emphysema after operation in each arm	within 30 days after surgery
Incidence of postoperative pneumothorax	The incidence of postoperative pneumothorax in each arm	within 30 days after surgery

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Minimally Invasive Surgery; Pneumonectomy; Chest Tubes
• Other Study ID Numbers: CDTM UNION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No