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出境医 / 临床实验 / The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung

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

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Lung Diseases Procedure: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung Procedure: Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung Not Applicable

Detailed 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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 1, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: avoiding chest drainage tube placement after resection of lung
This group of patients underwent avoiding chest drainage tube placement after VATS of the lung.
 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 resection of lung
This group of patients underwent indewlling chest drainage tube after VATS of the lung.
 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.
Outcome Measures
Primary Outcome Measures :
  1. operation time [ Time Frame: 1 day ]
    From the beginnning of ansesthesia to the end of anesthesia

  2. hospitalization expenses [ Time Frame: 15 days ]
    the total cost of hospitalzation

  3. postoperative complication rate [ Time Frame: a month ]
    incidence of postoperative complications such as pneumothorax and hydrohorax

  4. duration of postoperation pain [ Time Frame: 10 days ]
    postoperative pain duration

  5. VAS pain scores [ Time Frame: 3 days ]
    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.

  6. the time of early ambulation after operation [ Time Frame: 1 day ]
    the time from the patient's postoperative pushback to the first bedtime

  7. postoperative extubation time [ Time Frame: 1 day ]
    postoperative extubation time


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xueying Yang, M.D. 86-24-62255001 yangxy@sj-hospital.org

Locations
Layout table for location information
China, Liaoning
The Fourth Affiliated Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110004
Contact: Xueying Yang, M.D.         
Sponsors and Collaborators
Xueying Yang
Investigators
Layout table for investigator information
Principal Investigator: Xueying Yang, M.D. The Fourth Affiliated Hospital of China Medical University
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • operation time [ Time Frame: 1 day ]
    From the beginnning of ansesthesia to the end of anesthesia
  • hospitalization expenses [ Time Frame: 15 days ]
    the total cost of hospitalzation
  • postoperative complication rate [ Time Frame: a month ]
    incidence of postoperative complications such as pneumothorax and hydrohorax
  • duration of postoperation pain [ Time Frame: 10 days ]
    postoperative pain duration
  • VAS pain scores [ Time Frame: 3 days ]
    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.
  • the time of early ambulation after operation [ Time Frame: 1 day ]
    the time from the patient's postoperative pushback to the first bedtime
  • postoperative extubation time [ Time Frame: 1 day ]
    postoperative extubation time
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Official Title  ICMJE The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Lung Diseases
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: avoiding chest drainage tube placement after resection of lung
    This group of patients underwent avoiding chest drainage tube placement after VATS of the lung.
    Intervention: Procedure: avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung
  • indewlling chest drainage tube after resection of lung
    This group of patients underwent indewlling chest drainage tube after VATS of the lung.
    Intervention: Procedure: Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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. Review.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Xueying Yang, M.D. 86-24-62255001 yangxy@sj-hospital.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012554
Other Study ID Numbers  ICMJE EC-2019-HY-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: hospital cost and complications of postoperation
Supporting Materials: Study Protocol
Time Frame: data will become available in the next six month
Access Criteria: Feasibility and Safety of Postoperative Management Without Chest Tube Placement After VATS pneumoresection
URL: http://link-springer-com-cd.vtrus.net/content/pdf/10.1007%2Fs00595-010-4346-5.pdf
Responsible Party Xueying Yang, Shengjing Hospital
Study Sponsor  ICMJE Xueying Yang
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xueying Yang, M.D. The Fourth Affiliated Hospital of China Medical University
PRS Account Shengjing Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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