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

NCT ID: NCT04012554

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized controlled trial.The main study content is the feasibility and safety of avoiding chest tube placement after VATS of the lung,participants were 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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
This is a randomized controlled trial.Partcipants,Care Provider, and Investigator all know the grouping situation.The Investigator collect the information and observation indicators of the two groups of participant and send the outcomes.

Study Groups

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avoiding chest drainage tube placement after resection of lung

This group of patients underwent avoiding chest drainage tube placement after VATS of the lung.

Group Type EXPERIMENTAL

avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung

Intervention Type PROCEDURE

Avoiding chest drainage tube placement after VATS of the lung in the experiment group.

indewlling chest drainage tube after resection of lung

This group of patients underwent indewlling chest drainage tube after VATS of the lung.

Group Type OTHER

Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung

Intervention Type PROCEDURE

Indewlling chest drainage tube after VATS of lung in the control group.

Interventions

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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.

Intervention Type PROCEDURE

Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung

Indewlling chest drainage tube after VATS of lung in the control group.

Intervention Type PROCEDURE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xueying Yang

OTHER

Sponsor Role lead

Responsible Party

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Xueying Yang

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xueying Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Fourth Affiliated Hospital of China Medical University

Locations

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The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xueying Yang, M.D.

Role: CONTACT

86-24-62255001

Facility Contacts

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Xueying Yang, M.D.

Role: primary

References

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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/s00595-010-4346-5. Epub 2011 May 28.

Reference Type RESULT
PMID: 21626321 (View on PubMed)

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.

Reference Type RESULT
PMID: 27510705 (View on PubMed)

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.2018.04.75.

Reference Type RESULT
PMID: 29997933 (View on PubMed)

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.

Reference Type RESULT
PMID: 27865329 (View on PubMed)

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. doi: 10.1016/s0003-4975(98)00946-1.

Reference Type RESULT
PMID: 9875783 (View on PubMed)

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.

Reference Type RESULT
PMID: 27688029 (View on PubMed)

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. doi: 10.1016/j.ejcts.2004.01.041.

Reference Type RESULT
PMID: 15082297 (View on PubMed)

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: 10.1007/s00268-017-3975-x.

Reference Type RESULT
PMID: 28289835 (View on PubMed)

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-0037-1607443. Epub 2017 Oct 27.

Reference Type RESULT
PMID: 29078230 (View on PubMed)

Other Identifiers

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EC-2019-HY-023

Identifier Type: -

Identifier Source: org_study_id

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