About this trial
Video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus pleurodesis is the standard of care for recurrent primary spontaneous pneumothorax (PSP) or, in certain instances, after the first episode. The chest tube from surgery is typically kept to suction until post-operative day (POD) 2 to allow for scarring of the lung to the chest to prevent recurrence. However, the scarring process takes place over a period of weeks and is there no data to support POD#2 as the best time to remove the chest tube. Also, shorter chest tube duration can lower length of stay, patient discomfort, and hospital cost.
The goal of this randomized study is to determine if early removal (POD#1) of chest tube after video-assisted thoracoscopic surgery (VATS) with blebectomy/wedge resection plus chemical pleurodesis for primary spontaneous pneumothorax (PSP):
* has no worse 2-year recurrence rate compared to standard removal (POD#2) * will lower length of stay compared to standard removal * will result in less complications or re-interventions compared to standard removal
Participants will be asked to join prior to surgery. Following standard-of-care surgery, participants will be screened for randomization. If still eligible, participants will be randomized for early chest tube removal or standard removal. Early Removal will happen within 24 hours after surgery, with Standard Removal happening day 2 after surgery.
Participants will follow-up with the study team for 2 years on the following schedule:
* In clinic with a chest x-ray 2 weeks after surgery * By phone 3 months after surgery * In clinic with a chest x-ray 1 year after surgery * In clinic with a chest x-ray 2 years after surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax
Adult patients (> 18 years)
Disqualifiers
Subjects with history of chest radiation or prior ipsilateral chest surgery
Tuberculosis or other infectious etiology
Secondary spontaneous pneumothorax (COPD, cancer, cystic fibrosis, connective tissue disease, sarcoidosis, catamenial, etc.)
Pneumothorax due to trauma
Trial design
Parallel
Treatments tested in this trial
Early Chest Tube Removal
Procedure/SurgerySubjects within the "Early Removal" group will have their chest tube removed if the following criteria are met on the morning of POD#1: * ≤1 cm of apical pleural separation and no other areas of pleural separation * No air leak * No bloody output or concern for bleeding * \< 400cc of drainage
Standard Chest Tube Removal
Procedure/SurgerySubjects within the "Standard Removal" group will have their chest tube removal on POD#2 if the following criteria are met on the morning of POD#1: * ≤1 cm of apical pleural separation and no other areas of pleural separation * No air leak * No bloody output or concern for bleeding * \< 400cc of drainage
Apical Chest Tube
DeviceA single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of Pneumothorax
Secondary outcomes
Postoperative Length of Stay
Postoperative length of stay is defined from the end of the operation until discharge.
Total length of stay
Total length of stay is defined as the time from admission until time subject is discharged.
Chest Tube Duration
From the end of the operation until the removal of the chest tube placed at the initial VATS with pleurodesis.
Complications
Complications post-surgery such as pleural separation, pleural effusion, hemothorax, etc.
Sponsors and contacts
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