Surgery Clinical Trial
Official title:
Thoracoscopic Bullectomy With Absorbable Mesh Coverage of the Staple Line Versus Thoracoscopic Bullectomy Only for the Treatment of Primary Spontaneous Pneumothorax: a Single-blind, Parallel-group, Prospective, Randomized Controlled Trial
Primary spontaneous pneumothorax usually occurs in young, lean male without underlying lung disease. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or persisted air leakage. In recent years, thoracoscopic bullectomy with pleural abrasion is getting popular, thanks for the advance of endoscopic instruments and technique. The pneumothorax recurrence rate after thoracoscopic surgery is around 10%, which is significantly higher than that of thoracotomy. In addition, the rate of postoperative prolonged air leakage is 5-8%. The possible causes of recurrent pneumothorax and prolonged air leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a novel method using coverage of the endoscopic suture line by a large absorbable mesh during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, the investigators are conducting a prospective randomized trial in National Taiwan University Hospital. The investigators will enroll 204 patients with primary spontaneous pneumothorax who will be randomly assigned to additional mesh pleurodesis (mesh group, 102 patients) or not (control group, 102 patients) after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to compare the rate of pneumothorax recurrence within one year between the two groups. The secondary endpoints are to compare the safety, efficacy, and long-term pulmonary function between the two groups.
Status | Recruiting |
Enrollment | 204 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 50 Years |
Eligibility |
Inclusion criteria: 1. Age between 15 and 50 years old. 2. Spontaneous pneumothorax requiring thoracoscopic surgery. 3. With written inform consent Exclusion criteria: 1. With underlying pulmonary disease (chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, etc) 2. A history of previous ipsilateral thoracic operation 3. Diagnosis of catamenial pneumothorax 4. Diagnosis of lymphangioleiomyomatosis 5. Concurrent hemopneumothorax with bleeding > 500ml/h 6. Pregnant or lactating women 7. Other serious concomitant illness or medical conditions: 1. Congestive heart failure or unstable angina pectoris. 2. History of myocardial infarction within 1 year prior to the study entry. 3. Uncontrolled hypertension or arrhythmia. 4. History of significant neurologic or psychiatric disorders, including dementia or seizure. 5. Active infection requiring i.v. antibiotics. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital | Chang Gung Memorial Hospital, National Science Council, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the rates of ipsilateral pneumothorax recurrence | The detection of pneumothorax recurrence will be performed by chest radiography | 12 months | No |
Secondary | Safety of mesh coverage | Early postoperative results, including postoperative pain scores, postoperative duration of chest drainage, postoperative duration of hospital stay, and complication rates. | 30 days | Yes |
Secondary | long-term safety of mesh coverage | Long-term results, including residual chest pain at 6 months, and postoperative pulmonary function at 6 months. | 12 months | Yes |
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