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Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax

Primary Purpose

Primary Spontaneous Pneumothorax

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single chest tube drainage
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Spontaneous Pneumothorax focused on measuring number of chest tube, Bullectomy, Pleurodesis, Primary Spontaneous Pneumothorax

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax
  • Underwent bullectomy and pleurodesis
  • Postoperative indwelling chest tubes

Exclusion Criteria:

  • Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax
  • Previous surgery history
  • People with severe comorbidities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    single chest tube group

    multiple chest tubes group

    Arm Description

    Outcomes

    Primary Outcome Measures

    recurrence
    Recurrence of pneumothorax during 2 years follow-up

    Secondary Outcome Measures

    complications
    post-operation complications,such as air leakage

    Full Information

    First Posted
    April 2, 2021
    Last Updated
    October 9, 2021
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04831554
    Brief Title
    Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax
    Official Title
    Comparison of the Efficacy of Single Tube Versus Multiple Tubes Drainage After Bullectomy and Pleurodesis for Primary Spontaneous Pneumothorax
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 31, 2021 (Anticipated)
    Primary Completion Date
    May 1, 2023 (Anticipated)
    Study Completion Date
    October 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    There was no evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis.This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis. After routine procedure the participants will randomized to either placed single chest tube or multiple chest tubes
    Detailed Description
    Primary spontaneous pneumothorax (PSP) occurs after the rupture of small bullae or a subpleural bleb in otherwise normal lungs. The indications for surgical treatment include persistent air leak after intercostal tube drainage, recurrent PSP, and contralateral PSP. The video-assisted thoracoscopic surgery (VATS) approach probably represents the treatment of choice for PSP. The presence of a residual pleural space after surgery may be a factor associated with increased risk of recurrence. One possible hypothesis to explain the association between residual pleural space and recurrence of pneumothorax may be the failed pleurodesis due to lack of pleura-pleura apposition. Multiple chest tubes are effective in clinical practice, but there was no convinctive evidence that the number of chest tube do effect to the recurrence of pneumothorax, which placed after thoracoscopic wedge resection together with mechanical pleurodesis. This study evaluates the efficacy of single chest tube versus multiple tubes drainage in spontaneous pneumothorax after VATS bullectomy and pleurodesis.After routine procedure the participants will randomized to either placed multiple chest tubes or single chest tube. The recurrence of the two group and other postoperative clinical parameters will be observed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Spontaneous Pneumothorax
    Keywords
    number of chest tube, Bullectomy, Pleurodesis, Primary Spontaneous Pneumothorax

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single chest tube group
    Arm Type
    Experimental
    Arm Title
    multiple chest tubes group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    single chest tube drainage
    Intervention Description
    place single chest tube after surgery of PSP
    Primary Outcome Measure Information:
    Title
    recurrence
    Description
    Recurrence of pneumothorax during 2 years follow-up
    Time Frame
    2 years after operation
    Secondary Outcome Measure Information:
    Title
    complications
    Description
    post-operation complications,such as air leakage
    Time Frame
    30days after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed by chest radiograph or CT as primary spontaneous pneumothorax Underwent bullectomy and pleurodesis Postoperative indwelling chest tubes Exclusion Criteria: Secondary pneumothorax, traumatic pneumothorax and iatrogenic pneumothorax Previous surgery history People with severe comorbidities

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    24370202
    Citation
    Jiang L, Jiang G, Zhu Y, Hao W, Zhang L. Risk factors predisposing to prolonged air leak after video-assisted thoracoscopic surgery for spontaneous pneumothorax. Ann Thorac Surg. 2014 Mar;97(3):1008-13. doi: 10.1016/j.athoracsur.2013.10.031. Epub 2013 Dec 25.
    Results Reference
    background
    PubMed Identifier
    28457339
    Citation
    Sudduth CL, Shinnick JK, Geng Z, McCracken CE, Clifton MS, Raval MV. Optimal surgical technique in spontaneous pneumothorax: a systematic review and meta-analysis. J Surg Res. 2017 Apr;210:32-46. doi: 10.1016/j.jss.2016.10.024. Epub 2016 Nov 3.
    Results Reference
    background

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    Which is Better Between Single Chest Tube and Multiple Tubes Drainage in Primary Spontaneous Pneumothorax

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