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Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies

Primary Purpose

Non-Neoplastic Thoracic Disorder, Lung Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chest tube removal
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Non-Neoplastic Thoracic Disorder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy.
  • post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation.
  • patients with who read and signed informed consent regarding the participation of the study.

Exclusion Criteria:

  • Patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax.
  • patients who underwent thoracoscopic pleural biopsy for possible malignancy.
  • patients under 18 year old.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    chest tube removal after 3 hours

    delayed chest tube removal

    Arm Description

    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.

    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal according to the department's protocol, most probably post operative day 1 (POD1)

    Outcomes

    Primary Outcome Measures

    Non complicated early chest tube removal
    the patient with inclusion criteria can undergo early chest tube removal after three hours with no need for chest tube insertion, or pleural tapping for recurrent pleural effusion,
    Complicated early chest tube removal
    Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 29, 2016
    Last Updated
    April 4, 2016
    Sponsor
    Rambam Health Care Campus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02727218
    Brief Title
    Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies
    Official Title
    Effectiveness and Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Resection and Biopsies ; a Prospective Randomized Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rambam Health Care Campus

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be divided into two groups, the first group will undergo early chest tube removal - after three hours, the second group will have late chest tube removal according to the department's protocol. the study aims to prove the possibility and non inferiority for early chest tube removal for thoracoscopic surgeries with non complicated surgical course.
    Detailed Description
    Presence of chest tube post thoracoscopic surgery is associated with increased morbidities like wound infection, pain, and prolong the hospital admission Corse, in the other hand, early chest tube removal is associated with increased the need for recurrent active intervention like pleural tapping for re-accumulated pleural effusion. Method: randomized prospective study includes 60 patients who underwent thoracoscopic lobectomy/segmentectomy/ thoracoscopic mediastinal biopsy. The study will exclude patients with difficult operative course ( intraoperative finding of significant adhesions/ intraoperative injury of the lung parenchyma/ intraoperative bleeding/failure of extubation ) and patient with post operative findings of ( bleeding in the chest tube more than 100 ml in the first hour, persistent air leak, non expanded lung on chest x-ray ) The patients will be divided into two groups, the first group - 30 patients - will undergo chest tube removal after three hours, and the second group will undergo chest tube removal according to the treating department protocol. All patients will be evaluated regarding the pain level - subjective and objective -, admission period, infection, and the need for invasive intervention. The patients will be evaluated during the admission, after one week and after two weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Neoplastic Thoracic Disorder, Lung Diseases

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    chest tube removal after 3 hours
    Arm Type
    Experimental
    Arm Description
    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.
    Arm Title
    delayed chest tube removal
    Arm Type
    Active Comparator
    Arm Description
    30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal according to the department's protocol, most probably post operative day 1 (POD1)
    Intervention Type
    Procedure
    Intervention Name(s)
    Chest tube removal
    Intervention Description
    chest tube removal post thoracoscopic surgery
    Primary Outcome Measure Information:
    Title
    Non complicated early chest tube removal
    Description
    the patient with inclusion criteria can undergo early chest tube removal after three hours with no need for chest tube insertion, or pleural tapping for recurrent pleural effusion,
    Time Frame
    two weeks
    Title
    Complicated early chest tube removal
    Description
    Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.
    Time Frame
    two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy. post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation. patients with who read and signed informed consent regarding the participation of the study. Exclusion Criteria: Patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax. patients who underwent thoracoscopic pleural biopsy for possible malignancy. patients under 18 year old.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ran Kremer, MD
    Phone
    00972502063189
    Email
    r_kremer@rambam.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amit Katz, MD
    Phone
    00972502062291
    Email
    amit160275@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ran Kremer, MD
    Organizational Affiliation
    Rambam Health Care Campus
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12643377
    Citation
    Chang AC, Yee J, Orringer MB, Iannettoni MD. Diagnostic thoracoscopic lung biopsy: an outpatient experience. Ann Thorac Surg. 2002 Dec;74(6):1942-6; discussion 1946-7. doi: 10.1016/s0003-4975(02)04164-4.
    Results Reference
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    PubMed Identifier
    16495069
    Citation
    Gomez-Caro A, Roca MJ, Torres J, Cascales P, Terol E, Castaner J, Pinero A, Parrilla P. Successful use of a single chest drain postlobectomy instead of two classical drains: a randomized study. Eur J Cardiothorac Surg. 2006 Apr;29(4):562-6. doi: 10.1016/j.ejcts.2006.01.019. Epub 2006 Feb 21.
    Results Reference
    background
    PubMed Identifier
    18929492
    Citation
    Okur E, Baysungur V, Tezel C, Sevilgen G, Ergene G, Gokce M, Halezeroglu S. Comparison of the single or double chest tube applications after pulmonary lobectomies. Eur J Cardiothorac Surg. 2009 Jan;35(1):32-5; discussion 35-6. doi: 10.1016/j.ejcts.2008.09.009. Epub 2008 Oct 16.
    Results Reference
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    PubMed Identifier
    12437253
    Citation
    Younes RN, Gross JL, Aguiar S, Haddad FJ, Deheinzelin D. When to remove a chest tube? A randomized study with subsequent prospective consecutive validation. J Am Coll Surg. 2002 Nov;195(5):658-62. doi: 10.1016/s1072-7515(02)01332-7.
    Results Reference
    background
    PubMed Identifier
    22219425
    Citation
    Refai M, Brunelli A, Salati M, Xiume F, Pompili C, Sabbatini A. The impact of chest tube removal on pain and pulmonary function after pulmonary resection. Eur J Cardiothorac Surg. 2012 Apr;41(4):820-2; discussion 823. doi: 10.1093/ejcts/ezr126. Epub 2011 Dec 21.
    Results Reference
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    PubMed Identifier
    22379278
    Citation
    Yu H. Management of pleural effusion, empyema, and lung abscess. Semin Intervent Radiol. 2011 Mar;28(1):75-86. doi: 10.1055/s-0031-1273942.
    Results Reference
    background
    PubMed Identifier
    23872457
    Citation
    Bjerregaard LS, Jensen K, Petersen RH, Hansen HJ. Early chest tube removal after video-assisted thoracic surgery lobectomy with serous fluid production up to 500 ml/day. Eur J Cardiothorac Surg. 2014 Feb;45(2):241-6. doi: 10.1093/ejcts/ezt376. Epub 2013 Jul 19.
    Results Reference
    background
    PubMed Identifier
    17954081
    Citation
    McKenna RJ Jr, Mahtabifard A, Pickens A, Kusuanco D, Fuller CB. Fast-tracking after video-assisted thoracoscopic surgery lobectomy, segmentectomy, and pneumonectomy. Ann Thorac Surg. 2007 Nov;84(5):1663-7; discussion 1667-8. doi: 10.1016/j.athoracsur.2007.05.058.
    Results Reference
    background
    PubMed Identifier
    18242249
    Citation
    Cerfolio RJ, Bryant AS. Results of a prospective algorithm to remove chest tubes after pulmonary resection with high output. J Thorac Cardiovasc Surg. 2008 Feb;135(2):269-73. doi: 10.1016/j.jtcvs.2007.08.066.
    Results Reference
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    PubMed Identifier
    19464455
    Citation
    Nakanishi R, Fujino Y, Yamashita T, Oka S. A prospective study of the association between drainage volume within 24 hours after thoracoscopic lobectomy and postoperative morbidity. J Thorac Cardiovasc Surg. 2009 Jun;137(6):1394-9. doi: 10.1016/j.jtcvs.2008.10.035. Epub 2009 Mar 9.
    Results Reference
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    PubMed Identifier
    20833554
    Citation
    Gottgens KW, Siebenga J, Belgers EH, van Huijstee PJ, Bollen EC. Early removal of the chest tube after complete video-assisted thoracoscopic lobectomies. Eur J Cardiothorac Surg. 2011 Apr;39(4):575-8. doi: 10.1016/j.ejcts.2010.08.002. Epub 2010 Sep 15.
    Results Reference
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