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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient undergoing video assisted thoracoscopic surgery with blebectomy/wedge resection and chemical pleurodesis for primary spontaneous pneumothorax

• Adult patients (\> 18 years)

Locations
United States
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Contact Information
Primary
Brian Louie, M.D.
brian.louie@swedish.org
206-215-6800
Backup
John Campbell, M.D.
john.campbell@swedish.org
206-215-6800
Time Frame
Start Date: 2023-10-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 200
Treatments
Experimental: Early Chest Tube Removal
Subjects within the Early Removal group will have their chest tube removed on POD#1 within 24 hours from the end of the surgery.
Active_comparator: Standard Chest Tube Removal
Subjects in the Standard Removal group will have their chest tube kept to suction on POD#1 with removal on POD#2.
Related Therapeutic Areas
Sponsors
Leads: Swedish Medical Center

This content was sourced from clinicaltrials.gov