Back to resultsThe Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Primary Purpose
Lung Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung
Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Sponsored by
About this trial
This is an interventional treatment trial for Lung Diseases focused on measuring Postoperative pain, Avoiding chest drainage placement, Hospital cost
Eligibility 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).
Sites / Locations
- The Fourth Affiliated Hospital of China Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
avoiding chest drainage tube placement after resection of lung
indewlling chest drainage tube after resection of lung
Arm Description
This group of patients underwent avoiding chest drainage tube placement after VATS of the lung.
This group of patients underwent indewlling chest drainage tube after VATS of the lung.
Outcomes
Primary Outcome Measures
operation time
From the beginnning of ansesthesia to the end of anesthesia
hospitalization expenses
the total cost of hospitalzation
postoperative complication rate
incidence of postoperative complications such as pneumothorax and hydrohorax
duration of postoperation pain
postoperative pain duration
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.
the time of early ambulation after operation
the time from the patient's postoperative pushback to the first bedtime
postoperative extubation time
postoperative extubation time
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04012554
Brief Title
The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Official Title
The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xueying Yang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Postoperative pain, Avoiding chest drainage placement, Hospital cost
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
avoiding chest drainage tube placement after resection of lung
Arm Type
Experimental
Arm Description
This group of patients underwent avoiding chest drainage tube placement after VATS of the lung.
Arm Title
indewlling chest drainage tube after resection of lung
Arm Type
Other
Arm Description
This group of patients underwent indewlling chest drainage tube after VATS of the lung.
Intervention Type
Procedure
Intervention Name(s)
avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung
Intervention Description
Avoiding chest drainage tube placement after VATS of the lung in the experiment group.
Intervention Type
Procedure
Intervention Name(s)
Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung
Intervention Description
Indewlling chest drainage tube after VATS of lung in the control group.
Primary Outcome Measure Information:
Title
operation time
Description
From the beginnning of ansesthesia to the end of anesthesia
Time Frame
1 day
Title
hospitalization expenses
Description
the total cost of hospitalzation
Time Frame
15 days
Title
postoperative complication rate
Description
incidence of postoperative complications such as pneumothorax and hydrohorax
Time Frame
a month
Title
duration of postoperation pain
Description
postoperative pain duration
Time Frame
10 days
Title
VAS pain scores
Description
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.
Time Frame
3 days
Title
the time of early ambulation after operation
Description
the time from the patient's postoperative pushback to the first bedtime
Time Frame
1 day
Title
postoperative extubation time
Description
postoperative extubation time
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueying Yang, M.D.
Phone
86-24-62255001
Email
yangxy@sj-hospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueying Yang, M.D.
Organizational Affiliation
The Fourth Affiliated Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueying Yang, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
hospital cost and complications of postoperation
IPD Sharing Time Frame
data will become available in the next six month
IPD Sharing Access Criteria
Feasibility and Safety of Postoperative Management Without Chest Tube Placement After VATS pneumoresection
IPD Sharing URL
http://link-springer-com-cd.vtrus.net/content/pdf/10.1007%2Fs00595-010-4346-5.pdf
Citations:
PubMed Identifier
21626321
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/s00595-010-4346-5. Epub 2011 May 28.
Results Reference
result
PubMed Identifier
27510705
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.
Results Reference
result
PubMed Identifier
29997933
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.2018.04.75.
Results Reference
result
PubMed Identifier
27865329
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.
Results Reference
result
PubMed Identifier
9875783
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. doi: 10.1016/s0003-4975(98)00946-1.
Results Reference
result
PubMed Identifier
27688029
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.
Results Reference
result
PubMed Identifier
15082297
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. doi: 10.1016/j.ejcts.2004.01.041.
Results Reference
result
PubMed Identifier
28289835
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: 10.1007/s00268-017-3975-x.
Results Reference
result
PubMed Identifier
29078230
Citation
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.
Results Reference
result
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The Feasibility and Safety of Avoiding Chest Tube Placement After Video-assisted Thoracoscopic Surgery (VATS）of the Lung
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