Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01848860
First received: May 4, 2013
Last updated: April 12, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Spontaneous Pneumothorax
Surgery
Procedure: Thoracoscopic bullectomy and pleural abrasion
Biological: Mesh coverage of the staple line
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • the rates of ipsilateral pneumothorax recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The detection of pneumothorax recurrence will be performed by chest radiography


Secondary Outcome Measures:
  • Safety of mesh coverage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Early postoperative results, including postoperative pain scores, postoperative duration of chest drainage, postoperative duration of hospital stay, and complication rates.

  • long-term safety of mesh coverage [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Long-term results, including residual chest pain at 6 months, and postoperative pulmonary function at 6 months.


Estimated Enrollment: 204
Study Start Date: May 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control group
In this group, only thoracoscopic bullectomy and pleural abrasion will be done.
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.
Experimental: Mesh group
In this group, absorbable mesh coverage of the staple line will be performed after thoracoscopic bullectomy and pleural abrasion.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848860

Contacts
Contact: Jin-Shing Chen, MD, PhD 886-972651421 chenjs@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jin-Shing Chen, MD, PhD    02-23123456 ext 65178    chenjs@ntu.edu.tw   
Principal Investigator: Jin-Shing Chen, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jin-Shing Chen, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, Professor
ClinicalTrials.gov Identifier: NCT01848860     History of Changes
Other Study ID Numbers: 201211051DIC
Study First Received: May 4, 2013
Last Updated: April 12, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Pneumothorax
thoracoscopy
mesh
pleurodesis
treatment

Additional relevant MeSH terms:
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014