The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung

Lung Diseases Clinical Trial

Official title:

The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04012554
• Other study ID #: EC-2019-HY-023
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: October 2019
• Source: Shengjing Hospital
• Contact: Xueying Yang, M.D.
• Phone: 86-24-62255001
• Email: yangxy[@]sj-hospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after Video-Assisted Thoracoscopic Surgery lung disease,participants were randomly divided into experimental group and control group.Avoiding chest tube placement after VATS of the lung in the experimental group.Indwelling thoracic drainage tube after VATS of the lung in the control group.

Description:

This is a prospective randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,divided into experiment group and control group.Communicating with surgeon and patients who met the inclusion criteria,decided whether to enter the experimental group or control group. Experimental group avoid chest tube placement after VATS of the lung and control group indwell thoracic drainage tube after VATS of the lung.By collecting personal information of two groups of patients and the corresponding observation indicators to analyze whether the treatment of avoiding chest tube placement after VATS of the lung is more beneficial than the conventional indwell thoracic drainage tube after VATS of the lung,and it's safe and feasible.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 1.Age ranges from 18 to 75 years old,do the examination of chest CT showed pulmonary disease,no invasion of peripheral blood vessels and viscera,no pleural effusion and pericardial effusion.

2.Electrocardiogram, pulmonary function,color doppler ultrasound of the heart,arteries and veins of both lower limbs are normal,no potential infection was confirmed before surgery, no serious organic disease of the heart and lung,and no obvious operation contrain.

Exclusion Criteria:

• 1.The lungs continue to leak air preoperation more than six days. 2.The appearment of the hemothorax,empyema and chylothorax preoperative. 3.The appearment of the preoperative chest X-ray pulmonary atelectasis and pulmonary infection.

4.The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.

6.Impaired lung function (forced expiratory volume in 1 second [FEV1]<60% predicted).

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Procedure:
• avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung
Avoiding chest drainage tube placement after VATS of the lung in the experiment group.
• Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Indewlling chest drainage tube after VATS of lung in the control group.

Locations

Country	Name	City	State
China	The Fourth Affiliated Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Xueying Yang

Country where clinical trial is conducted

China, 

References & Publications (9)

Chiappetta M, Lococo F, Nachira D, Ciavarella LP, Congedo MT, Porziella V, Meacci E, Margaritora S. Digital Devices Improve Chest Tube Management: Results from a Prospective Randomized Trial. Thorac Cardiovasc Surg. 2018 Oct;66(7):595-602. doi: 10.1055/s- — View Citation

Deng B, Qian K, Zhou JH, Tan QY, Wang RW. Optimization of Chest Tube Management to Expedite Rehabilitation of Lung Cancer Patients After Video-Assisted Thoracic Surgery: A Meta-Analysis and Systematic Review. World J Surg. 2017 Aug;41(8):2039-2045. doi: 1 — View Citation

Filosso PL, Sandri A, Guerrera F, Roffinella M, Bora G, Solidoro P. Management of Chest Drains After Thoracic Resections. Thorac Surg Clin. 2017 Feb;27(1):7-11. doi: 10.1016/j.thorsurg.2016.08.002. Review. — View Citation

Holbek BL, Hansen HJ, Kehlet H, Petersen RH. Thoracoscopic pulmonary wedge resection without post-operative chest drain: an observational study. Gen Thorac Cardiovasc Surg. 2016 Oct;64(10):612-7. doi: 10.1007/s11748-016-0692-6. Epub 2016 Aug 10. — View Citation

Li P, Shen C, Wu Y, Lai Y, Zhou K, Che G. It is safe and feasible to omit the chest tube postoperatively for selected patients receiving thoracoscopic pulmonary resection: a meta-analysis. J Thorac Dis. 2018 May;10(5):2712-2721. doi: 10.21037/jtd.2018.04. — View Citation

Lu TY, Chen JX, Chen PR, Lin YS, Chen CK, Kao PY, Huang TM, Fang HY. Evaluation of the necessity for chest drain placement following thoracoscopic wedge resection. Surg Today. 2017 May;47(5):606-610. doi: 10.1007/s00595-016-1414-5. Epub 2016 Sep 29. — View Citation

Nakashima S, Watanabe A, Mishina T, Obama T, Mawatari T, Higami T. Feasibility and safety of postoperative management without chest tube placement after thoracoscopic wedge resection of the lung. Surg Today. 2011 Jun;41(6):774-9. doi: 10.1007/s00595-010-4 — View Citation

Russo L, Wiechmann RJ, Magovern JA, Szydlowski GW, Mack MJ, Naunheim KS, Landreneau RJ. Early chest tube removal after video-assisted thoracoscopic wedge resection of the lung. Ann Thorac Surg. 1998 Nov;66(5):1751-4. — View Citation

Watanabe A, Watanabe T, Ohsawa H, Mawatari T, Ichimiya Y, Takahashi N, Sato H, Abe T. Avoiding chest tube placement after video-assisted thoracoscopic wedge resection of the lung. Eur J Cardiothorac Surg. 2004 May;25(5):872-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operation time	From the beginnning of ansesthesia to the end of anesthesia	1 day
Primary	hospitalization expenses	the total cost of hospitalzation	15 days
Primary	postoperative complication rate	incidence of postoperative complications such as pneumothorax and hydrohorax	a month
Primary	duration of postoperation pain	postoperative pain duration	10 days
Primary	VAS pain scores	the VAS pain score was given to patients and the pain scores were recorded at 6h,12h,24h,48h,and 72h postoperatively.The minimum score is 0 and the maximum score is 10.The high values represent a worse outcome.	3 days
Primary	the time of early ambulation after operation	the time from the patient's postoperative pushback to the first bedtime	1 day
Primary	postoperative extubation time	postoperative extubation time	1 day