Clinical Trial: Additional Minocycline Pleurodesis After Thoracoscopic Procedures for Primary Spontaneous Pneumothorax
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase III Study of Additional Minocycline Pleurodesis After Video-Assisted Thoracoscopic Surgery for Primary Spontaneous Pneumothorax
Brief Summary: To test if additional minocycline pleurodesis after thoracoscopic procedures can reduce the rates of ipsilateral recurrence for patients with primary spontaneous pneumothorax.
Detailed Summary:
Patients and Methods Study design This study is a randomized trial of additional minocycline pleurodesis after VATS for primary spontaneous pneumothorax. It was begun in June 2001 in Thoracic Surgical Division, National Taiwan University Hospital. After VATS for primary spontaneous pneumothorax, eligible patients were randomly assigned to additional minocycline pleurodesis or observation. The primary end point was rate of ipsilateral recurrence after the operation. Secondary end points included safety, early postoperative results, and long-term effects of minocycline pleurodesis. Consents were obtained from patients after thorough explanation. The protocol was approved by the Institutional Review Board of National Taiwan University Hospital.
Eligibility criteria All patients requiring VATS caused by ipsilateral recurrence, continuous air leaks for > 3 days, contralateral recurrence, presence of hemopneumothorax, or uncomplicated first episode with professions at risk were eligible for this study. The exclusion criteria were: greater than 50 years of age, underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwillingness to randomization.
Operative technique of VATS After confirmation of patient eligibility, either conventional or needlescopic VATS was performed for these patients by his or her own choice. The cost of the operation and cosmetic results were the main points considered by the patients as they made their choices. The cost of needlescopic VATS is higher than that of conventional VATS because our National Health Insurance will cover only a part of the disposable equipment. Our previous study showed that the short-term results and recurrence rates of both techniques were comparable, although needlescopic VATS provides better cosmetic results and les
Sponsor: National Taiwan University Hospital
Current Primary Outcome: The primary end point was rates of ipsilateral recurrence after the operation.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- safety of minocycline
- early postoperative results of minocycline
- long-term complication of minocycline
- long-term effect on pulmonary function of minocycline pleurodesis
Original Secondary Outcome: Same as current
Information By: National Taiwan University Hospital
Dates:
Date Received: September 8, 2005
Date Started: June 2001
Date Completion: March 2005
Last Updated: October 19, 2005
Last Verified: June 2001
