RecruitingNot Applicable

Early Chest Tube Removal After Surgery for Primary Spontaneous Pneumothorax: A Randomized Controlled Trial

United States200 participantsStarted 2023-10-03

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax * Adult patients (\> 18 years) Exclusion Criteria: * 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 * Hemothorax or hydropneumothorax * Immunocompromised subjects: neutropenic, leukopenia, or subjects taking immunosuppressive medication such as chemotherapy, transplant medications, steroid (≥5 mg of prednisone or equivalent), etc. * Interstitial lung disease * Children (\<18) * Pregnant women * Adults unable to consent for themselves * Prisoners

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recurrence of Pneumothorax

Timeframe: 2 years from surgery

Trial details

NCT IDNCT06411431

SponsorSwedish Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Brian Louie, M.D.

206-215-6800 brian.louie@swedish.org

View on ClinicalTrials.gov More Primary Spontaneous Pneumothorax trials