Clinical Trial: Chest Tube Drainage or Thoracoscopic Surgery for Failed Aspiration of Spontaneous Pneumothorax
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Comparison of Chest Tube Drainage Versus Thoracoscopic Surgery for Unsuccessful Aspiration of Primary Spontaneous Pneumothorax: a Prospective Randomized Trial
Brief Summary: We hypothesize that VATS is more effective than CTD for management of primary spontaneous pneumothorax with aspiration failure. To this end, we will compare two groups of patients who had experienced unsuccessful aspiration of primary spontaneous pneumothorax stratified by treatment.
Detailed Summary:
Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males [1, 2]. Optimal management for a first episode of this benign disease has been a matter of debate. In the recently published BTS guidelines [3], simple aspiration is recommended as the first-line treatment for all primary pneumothoraces requiring intervention because it appears to be as effective as chest tube drainage (CTD), as well as safe, well tolerated and feasible in an outpatient setting in the majority of cases [3]. When simple aspiration was unsuccessful, which occurred in about 15-62% of all pneumothoraces requiring intervention, chest tube drainage is recommended [3-12]. However, many prospective studies that have compared simple aspiration and tube drainage for primary spontaneous pneumothorax have shown that they are equally effective for treatment of primary spontaneous pneumothorax in terms of success and recurrence rates [4, 11, 12]. In this regard, chest tube drainage provides no benefits in unsuccessful aspiration of primary spontaneous pneumothorax because the rates of persistent air leakage and recurrence remain the same.
Advances in video-assisted thoracoscopic surgery (VATS) have made it a safe, less-invasive and more-effective intervention for treating recurrent pneumothorax or persistent air leakage after CTD [13-15]. However, the role of VATS in the management of first primary spontaneous pneumothorax where aspiration has failed remains unclear. Theoretically, unsuccessful aspiration is usually associated with large or persistent air leaks. Definitive treatment would include elimination of air leakage and, if possible, recurrence. Under such consideration, VATS with bullectomy and mechanical pleurodesis provides a good alternative in terms of achieving these therapeutic goals. We hypothesize that VATS is more effective than CTD for management of primary spontaneous pn
Sponsor: National Taiwan University Hospital
Current Primary Outcome: Comparing the number of days in hospital, after intervention, of each group. [ Time Frame: within one month ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Short-term outcome, including number of days with chest drainage, total hospital stay, short-term failure rate of assigned treatment, adverse events, pain score, mean dose of meperidine requested. [ Time Frame: within one month ]
- Long-term outcome, including recurrence rate and long-term failure rate of assigned treatment [ Time Frame: 2 years ]
- Total costs of each patients in assigned treatment. [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: National Taiwan University Hospital
Dates:
Date Received: July 9, 2008
Date Started: April 2008
Date Completion: September 2013
Last Updated: December 13, 2012
Last Verified: November 2012
