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

Not Applicable

• Conditions: Primary Spontaneous Pneumothorax
• Interventions: Procedure: single chest tube drainage

• Registration Number: NCT04831554
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-05
• Last Update Submitted: 2021-10-09
• Last Update Posted: 2021-10-18
• Study Start: 2021-10-31
• Primary Completion: 2023-05-01
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single chest tube group	single chest tube drainage	-

Primary Outcome Measures

Name	Time	Method
recurrence	2 years after operation	Recurrence of pneumothorax during 2 years follow-up

Secondary Outcome Measures

Name	Time	Method
complications	30days after operation	post-operation complications，such as air leakage