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
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
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
NCT ID
NCT04831554
First Posted
April 2, 2021
Last Updated
October 9, 2021
Sponsor
Peking University Third Hospital
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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