Clinical trial NCT04831554: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Spontaneous Pneumothorax
Keywords: number of chest tube
Bullectomy
Pleurodesis
Primary Spontaneous Pneumothorax
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: recurrence
timeFrame: 2 years after operation
Secondary outcomes:
measure: complications
timeFrame: 30days after operation
Other outcomes:
Locations:
Study officials:
References:
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.
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.