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NCT07331805
The goal of this randomized clinical trial is to find out whether a conservative management strategy (active observation without an initial invasive procedure) can treat as effectively as the standard treatment with chest tube drainage in adults with a large primary spontaneous pneumothorax who are clinically stable. Participants include men and women 18 to 60 years old with a lung collapse ≥30% (by Collins method). The main questions are: * Is conservative management not inferior to chest tube drainage for achieving complete lung re-expansion at 8 weeks (on chest X-ray)? * What are the differences between the two strategies in complications, recurrence at 2 years, quality of life, length of hospital stay, number of additional procedures, and healthcare costs? Comparison groups: * Conservative management: in-hospital observation with a control chest X-ray no earlier than 4 hours; if the person remains stable, discharge home with scheduled outpatient follow-up and serial X-rays until resolution. * Standard treatment (chest tube): chest tube placement and hospital admission; discharge based on clinical progress with routine outpatient follow-up. Researchers will compare both groups to see whether conservative management works just as well to resolve the pneumothorax at 8 weeks and whether it leads to fewer complications, shorter hospital stays, better quality of life, and lower costs. What will participants be asked to do? Review the participant information sheet and sign informed consent. Be randomized by computer (REDCap) to either conservative management or chest tube drainage. Depending on the assigned group: * Conservative group: remain under observation initially, have a chest X-ray at ≥4 hours; if still stable, go home with clinic visits (about 1 week after discharge and then every \~2 weeks) until the pneumothorax has resolved. * Chest tube group: undergo chest tube insertion, stay in the hospital, and attend routine outpatient follow-up after discharge. Undergo chest X-rays interpreted by the clinical team (with centralized review procedures). Complete brief symptom assessments, quality-of-life questionnaires (e.g., EQ-5D-5L), and attend follow-up visits or phone calls for up to 2 years to check for recurrences. This is a multicenter study conducted in several hospitals in Spain. The planned sample size is 436 participants (218 per group), with a non-inferiority margin of 5% and the primary assessment at 8 weeks.
NCT06411431
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
NCT06413966
This is a prospective, randomized controlled trial (pilot study) that aims to determine the incidence of post-operative recurrent pneumothorax within one-year timeframe after video-assisted thoracoscopic blebectomy/bullectomy with either apical pleurectomy or partially absorbable mesh, as well as to assess the efficacy in preventing post-operative recurrence pneumothorax. Patients, aged more than or equal 20-year-old, with the diagnosis of primary spontaneous pneumothorax, who require video-assisted thoracoscopic surgery at Maharaj Nakorn Chiangmai Hospital, Chiang Mai University, Chiang Mai, Thailand, will be enrolled into this study. The inform consent will be obtained before the enrollment. Patients will be randomized to two groups; Partially absorbable mesh coverage group (intervention group) and Apical pleurectomy group (control group).
NCT04831554
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
NCT02866305
Knowledge about incidence, risk factors and genetic predispositions of primary spontaneous pneumothorax in young adults is very limited, and treatment has also been controversial.The Aim of this study is to optimize the treatment, estimate the actual incidence, and identify possible risk factors including genetic predispositions.
NCT02109510
Investigators compared the patients' subjective postoperative symptoms and complications between the double lumen endotracheal intubated patients under general anesthesia and non-intubated patients under sedation and local anesthesia including 1. postoperative Visual scale of pain 2. postoperative sore throat/voice change 3. postoperative nausea/vomiting 4. intraoperative Arterial blood gas analysis 5. cost for anesthesia 6. morbidity