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

NCT04012554 | Unknown DMC

• 1 other identifier: EC-2019-HY-023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Postoperative pain; Avoiding chest drainage placement; Hospital cost

Outcome Measures

Primary Outcomes (7)

• operation time

  From the beginnning of ansesthesia to the end of anesthesia

  1 day

• hospitalization expenses

  the total cost of hospitalzation

  15 days

• postoperative complication rate

  incidence of postoperative complications such as pneumothorax and hydrohorax

  a month

• duration of postoperation pain

  postoperative pain duration

  10 days

• 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

• the time of early ambulation after operation

  the time from the patient's postoperative pushback to the first bedtime

  1 day

• postoperative extubation time

  postoperative extubation time

  1 day

Study Arms (2)

avoiding chest drainage tube placement after resection of lung

EXPERIMENTAL

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

indewlling chest drainage tube after resection of lung

OTHER

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

Interventions

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

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

avoiding chest drainage tube placement after resection of lung

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

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

indewlling chest drainage tube after resection of lung

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• 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.

You may not qualify if:

• 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.
• The lungs leak air appears in the surgery. 5.Patients with severe cardiovascular and cerebrovascular accident after operation were terminated.
• Impaired lung function (forced expiratory volume in 1 second \[FEV1\]\<60% predicted).

Sponsors & Collaborators

• Xueying Yang: lead

Study Sites (1)

The Fourth Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 21626321 RESULT

• 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.

  PMID: 27510705 RESULT

• 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.

  PMID: 29997933 RESULT

• 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.

  PMID: 27865329 RESULT

• 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.

  PMID: 9875783 RESULT

• 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.

  PMID: 27688029 RESULT

• 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.

  PMID: 15082297 RESULT

• 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.

  PMID: 28289835 RESULT

• 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.

  PMID: 29078230 RESULT

MeSH Terms

Conditions

Lung Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Xueying Yang, M.D.

  The Fourth Affiliated Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueying Yang, M.D.

CONTACT

86-24-62255001; yangxy@sj-hospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: July 2, 2019
• First Posted: July 9, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

CN (1)