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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):
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:
This study will be a multicentered randomized controlled trial. The trial will recruit all adult subjects (>18 years old) with PSP who are undergoing VATS blebectomy/wedge resection with chemical pleurodesis from participating centers. Subjects will be identified by the surgical team when evaluating a subject with PSP for surgery. If screened eligible and not meeting an exclusion criterion, the trial will be discussed with them, and consent will be obtained.
Subjects will undergo VATS with resection of all visible disease or an apical wedge resection if none is found. The use of reinforced or non-reinforced staple loads is left to surgeons' preference. For pleurodesis, choice of chemical agent is at the desecration of the surgeon and common practice but limited to 3 agents (talc, dextrose, or a tetracycline antibiotic). Surgeons can choose to perform a mechanical pleurodesis as they deem appropriate. A single apical chest tube will be placed and connected to a suction device set to at least -20 mmHg of suction. Subjects will then be admitted overnight.
Subjects will be re-evaluated on the morning of POD#1. Those without an air leak, with <400 cc of non-bloody chest tube output, and having a maximum 1cm of apical pleural separation (as determined by the surgeon) will be eligible for randomization to either early or standard removal of their chest tube.
Randomization will occur in a 1:1 manner, stratified by participating center. Subjects within the "Early Removal" group will have their chest tube removed on postoperative day 1 within 24 hours from the end of the surgery with a follow-up chest x-ray within 6 hours from removal in addition to monitoring of symptoms. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or increased pleural separation on x-ray, they will be eligible for discharge with appropriate follow-up.
Subjects in the "Standard Removal" group will keep their chest tube to suction until postoperative day 2. The chest tube would be removed on POD#2 with a follow up chest x-ray within 6 hours. If the subject remains stable without developing symptoms (new oxygen requirement, shortness of breath, etc.) or growth of pleural separation on chest x-ray, they would be eligible for discharge.
Subjects will then follow up in clinic within 2 weeks of the operation with a chest x-ray. A 3-month follow-up phone call will be performed. At 1-year post-operative, subjects again will have standard clinic follow up and chest x-ray. Finally, a 2 year follow up phone call and chest x-ray will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Chest Tube Removal | Experimental | Subjects within the "Early Removal" group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery. |
|
| Standard Chest Tube Removal | Active Comparator | Subjects in the "Standard Removal" group will have their chest tube kept to suction on POD#1 with removal on POD#2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Chest Tube Removal | Procedure | Subjects within the "Early Removal" group will have their chest tube removed if the following criteria are met on the morning of POD#1:
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Pneumothorax | 2 years from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Length of Stay | Postoperative length of stay is defined from the end of the operation until discharge. | End of Surgery to Discharge, up to 90 days |
| Total length of stay | Total length of stay is defined as the time from admission until time subject is discharged. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Louie, M.D. | Contact | 206-215-6800 | brian.louie@swedish.org | |
| John Campbell, M.D. | Contact | 206-215-6800 | john.campbell@swedish.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Cancer Institute | Recruiting | Seattle | Washington | 98104 | United States |
No plan to share IPD
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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Surgical intervention and related care will follow current standard practices with the following items representing the randomized arms under investigation:
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| Standard Chest Tube Removal | Procedure | Subjects 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:
|
|
| Apical Chest Tube | Device | A single apical chest tube will be placed and connected to a suction device at least -20 mmHg suction. |
|
| Admission to Discharge, up to 90 days |
| Chest Tube Duration | From the end of the operation until the removal of the chest tube placed at the initial VATS with pleurodesis. | End of surgery to removal of chest tube, up to 90 days |
| Complications | Complications post-surgery such as pleural separation, pleural effusion, hemothorax, etc. | 2 years from surgery |
| Need for interventions | Need for additional interventions post-surgery such as thoracentesis, chest tube placement, etc. | 2 years from surgery |