Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax

Summary

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.

Conditions

• Spontaneous Pneumothorax
• Surgery

Interventions

PROCEDURE

Thoracoscopic bullectomy and pleural abrasion

Thoracoscopic bullectomy and pleural abrasion will be performed in a standard fashion under general anesthesia using intubated one-lung ventilation. When blebs are identified, they will be grasped with the ring forceps and excised with an endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. Thoracoscopic pleural abrasion will be performed at the parietal pleura above the 5th intercostal space by inserting the dissector with a strip of diathermy scratch pad through the port sites in all patients.

BIOLOGICAL

Mesh coverage of the staple line

Absorbable mesh coverage of the staple line will be performed in the mesh group after thoracoscopic bullectomy in the mesh group

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• Chang Gung Memorial Hospital

  collaborator OTHER

• National Taiwan University Hospital

  lead OTHER

Principal Investigators

• Jin-Shing Chen, MD, PhD · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• Taiwan

Study Locations