Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848860
Recruitment Status : Unknown
Verified July 2015 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : July 8, 2015
Sponsor:
Collaborators:
National Science Council, Taiwan
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE May 4, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date July 8, 2015
Study Start Date  ICMJE May 2013
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
the rates of ipsilateral pneumothorax recurrence [ Time Frame: 12 months ]
The detection of pneumothorax recurrence will be performed by chest radiography
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2013)
  • Safety of mesh coverage [ Time Frame: 30 days ]
    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 ]
    Long-term results, including residual chest pain at 6 months, and postoperative pulmonary function at 6 months.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Absorbable Mesh Pleurodesis in Thoracoscopic Treatment of Spontaneous Pneumothorax
Official Title  ICMJE 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
Brief 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.
Detailed Description

Primary spontaneous pneumothorax most commonly occurs in young, tall, lean males (1, 2). The estimated recurrence rate is 23-50% after the first episode and increases to 60% after the second pneumothorax (3). Optimal management of this benign disease, especially after repeat attack, has been a matter of debate. Recent advances in video-assisted thoracoscopic surgery (VATS) that combine bullectomy with pleural abrasion provide a preferred intervention for treating primary spontaneous pneumothorax (4-6). Unfortunately, recurrence rates of pneumothorax after VATS range between 5% and 10%, which are higher than the rates reported after open thoracotomy (7-11). It is suggested that a higher chance of missed leaking blebs around the staple line of endoscopic staplers (12) and a less intense pleural inflammatory reaction are induced by VATS procedure than by thoracotomy (13, 14). In addition, postoperative air leakage usually occurs at the staple line. (7, 15) As a result, the efficacy of VATS is questioned and more aggressive procedures, such as limited thoracotomy with pleurectomy, are sometimes performed to enhance the effects of pleural symphysis (10, 14).

Theoretically, reinforcement of the visceral pleura around the staple line is a reasonable way to prevent postoperative air leak and recurrent pneumothorax. Previous retrospective studies showed that staple line coverage with absorbable mesh after thoracoscopic bullectomy is safe and may be effective in decreasing the rates of pneumothorax recurrence (16,17). One animal study also showed that when absorbable mesh insertion is coupled with pleural abrasion, appropriate pleurodesis is predictably achieved (18).

In the present study, additional absorbable mesh coverage of the staple line will be randomly administered in patients with primary spontaneous pneumothorax after VATS to test the efficacy and safety of this method.

References

  1. Gobbel WG Jr, Rhea WG, Nelson IA, Daniel RA Jr. Spontaneous pneumothorax. J Thorac Cardiovasc Surg 1963;46:331-345.
  2. Lichter J, Gwynne JF. Spontaneous pneumothorax in young subjects. Thorax 1971;25:409-417.
  3. Light RW. Management of spontaneous pneumothorax. Am Rev Respir Dis 1993;148:245-258.
  4. Baumann MH, Strange C, Heffner JE, Light R, Kirby TJ, Klein J, Luketich JD, Panacek EA, Sahn SA; AACP Pneumothorax Consensus Group. Management of spontaneous pneumothorax: an American College of Chest Physicians Delphi consensus statement. Chest 2001;119:590-602.
  5. Naunheim KS, Mack MJ, Hazelrigg SR, Ferguson MK, Ferson PF, Boley TM, Landreneau RJ. Safety and efficacy of video-assisted thoracic surgical techniques for the treatment of spontaneous pneumothorax. J Thorax Cardiovasc Surg 1995;109:1198-1204.
  6. Mouroux J, Elkaim D, Padovani B, Myx A, Perrin C, Rotomondo C, Chavaillon JM, Blaive B, Richelme H. Video-assisted thoracoscopic treatment of spontaneous pneumothorax: technique and results of one hundred cases. J Thorac Cardiovasc Surg 1996;112:385-391.
  7. Hatz RA, Kaps MF, Meimarakis G, Loehe F, Muller C, Furst H. Long-term results after video-assisted thoracoscopic surgery for first-time and recurrent spontaneous pneumothorax. Ann Thorac Surg 2000;70:253-257.
  8. Inderbitzi RG, Leiser A, Furrer M, Althaus U. Three years' experience in video-assisted thoracic surgery (VATS) for spontaneous pneumothorax. J Thorac Cardiovasc Surg 1994;107:1410-1415.
  9. Chan P, Clarke P, Daniel FJ, Knight SR, Seevanayagam S. Efficacy study of video-assisted thoracoscopic surgery pleurodesis for spontaneous pneumothorax. Ann Thorac Surg 2001;71:452-454.
  10. Massard G, Thomas P, Wihlm JM. Minimally invasive management for first and recurrent pneumothorax. Ann Thorac Surg 1998;66:592-599.
  11. Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med 2000;342:868-874.
  12. Sakamoto K, Kase M, Mo M, et al. Regrowth of bullae around the staple-line is one of the causes of postoperative recurrence in thoracoscopic surgery for spontaneous pneumothorax. Kyobu Geka 1999;52:939-42.
  13. Gebhard FT, Becker HP, Gerngross H, Bruckner UB. Reduced inflammatory response in minimally invasive surgery of pneumothorax. Arch Surg 1996;131:1079-1082.
  14. Horio H, Nomori H, Fuyuno G, Naruke T, Suemasu K. Limited axillary thoracotomy vs video-assisted thoracoscopic surgery for spontaneous pneumothorax. Surg Endosc 1998:12:1155-1158.
  15. How CH, Tsai TM, Duo SW, et al. Chemical pleurodesis for prolonged postoperative air leak in primary spontaneous pneumothorax. J Formos Med Assoc, accepted.
  16. Nakanishi K. An apical symphysial technique using a wide absorbable mesh placed on the apes for primary spontaneous pneumothorax. Surg Endosc 2009;23:2515-2521.
  17. Sakamoto K, Takei H, Nishii T, et al. Staple line coverage with absorbable mesh after thoracoscopic bullectomy for spontaneous pneumothorax. Surg Endosc 2004;18:478-481.
  18. Suqarmann WM, Widmann WD, Mysh D, et al. Mesh insertion as an aid for pleurodesis. J Cardiovasc Surg 1996;37:173-5.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Spontaneous Pneumothorax
  • Surgery
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Sham Comparator: Control group
    In this group, only thoracoscopic bullectomy and pleural abrasion will be done.
    Intervention: Procedure: Thoracoscopic bullectomy and pleural abrasion
  • Experimental: Mesh group
    In this group, absorbable mesh coverage of the staple line will be performed after thoracoscopic bullectomy and pleural abrasion.
    Interventions:
    • Procedure: Thoracoscopic bullectomy and pleural abrasion
    • Biological: Mesh coverage of the staple line
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 7, 2013)
204
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848860
Other Study ID Numbers  ICMJE 201211051DIC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE
  • National Science Council, Taiwan
  • Chang Gung Memorial Hospital
Investigators  ICMJE
Principal Investigator: Jin-Shing Chen, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP