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DSMB recommended termination on the basis of poor accrual rate. We will transition to a prospective observational (non-randomized) study design.
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The purpose of this study is to compare the effectiveness of two treatment strategies--delayed versus immediate surgery-- for children with primary spontaneous pneumothorax (collapse of the lung). Currently, both treatment modalities are used and there is no clear evidence that either option is superior. The investigators hypothesize that immediate surgery will have better outcomes with lower recurrence rates than delayed surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Surgery Group | Active Comparator | Patients randomized to the primary surgical intervention group will undergo VATS (video-assisted thoracoscopic surgery), apical blebectomy and mechanical pleurodesis during the initial hospital admission by the admitting staff surgeon. The general principles of the surgical technique consist of a 3-port thoracoscopic approach, stapled blebectomy, apical mechanical pleurodesis, and placement of chest tube . Variations of this technique will be at the discretion of the surgeon. |
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| Initial Non-operative management | Active Comparator | Those randomized to the control group will be admitted and their chest tube or percutaneous drainage catheter managed according to standard protocol. This consists of a minimum of 48 hours of Pleur-Evac suction and daily chest radiographs. The drainage tube is then placed to water seal when resolution of the pneumothorax is documented by x-ray, as well as absence of an air leak. If there are no clinical or radiographic changes after a water seal period, the chest tube is then removed. A post-removal chest radiograph is obtained and the patient is discharged if clinical and radiographic criteria are met. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Surgery Group | Procedure | Patients will receive surgical intervention during the initial hospital admission, as previously described, for the spontaneous pneumothorax. Patients will then be admitted postoperatively and monitored until discharge criteria are met |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period. | 1 month |
| Recurrence rate | The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period. | 3 months |
| Recurrence rate | The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period. | 6 months |
| Recurrence rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Surgical site infection (NSQIP definition), persistent air leak (> 4 days), and prolonged need for chest tube (as quantified by number of chest tube days) | 30 days |
| Hospital Length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Monica E Lopez, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10727592 | Background | Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. doi: 10.1056/NEJM200003233421207. No abstract available. | |
| 22453728 | Background | Dotson K, Timm N, Gittelman M. Is spontaneous pneumothorax really a pediatric problem? A national perspective. Pediatr Emerg Care. 2012 Apr;28(4):340-4. doi: 10.1097/PEC.0b013e31824d9a65. |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| Initial Non-operative management | Procedure | Patients will receive percutaneous drainage or chest tube placement as initial management for spontaneous pneumothorax. This will be followed by an observation period until discharge criteria are met. |
|
| 1 month |
| Time to return to normal activities | 1 month, 3 months, 6 months, 12 months |
| Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department) | 1 month |
| 19651381 | Background | Robinson PD, Cooper P, Ranganathan SC. Evidence-based management of paediatric primary spontaneous pneumothorax. Paediatr Respir Rev. 2009 Sep;10(3):110-7; quiz 117. doi: 10.1016/j.prrv.2008.12.003. Epub 2009 May 21. |
| 18041754 | Background | O'Lone E, Elphick HE, Robinson PJ. Spontaneous pneumothorax in children: when is invasive treatment indicated? Pediatr Pulmonol. 2008 Jan;43(1):41-6. doi: 10.1002/ppul.20734. |
| 8067834 | Background | Waller DA, Forty J, Morritt GN. Video-assisted thoracoscopic surgery versus thoracotomy for spontaneous pneumothorax. Ann Thorac Surg. 1994 Aug;58(2):372-6; discussion 376-7. doi: 10.1016/0003-4975(94)92210-1. |
| 9788848 | Background | Kim J, Kim K, Shim YM, Chang WI, Park KH, Jun TG, Park PW, Chae H, Lee KS. Video-assisted thoracic surgery as a primary therapy for primary spontaneous pneumothorax. Decision making by the guideline of high-resolution computed tomography. Surg Endosc. 1998 Nov;12(11):1290-3. doi: 10.1007/s004649900842. |
| 8252960 | Background | Donahue DM, Wright CD, Viale G, Mathisen DJ. Resection of pulmonary blebs and pleurodesis for spontaneous pneumothorax. Chest. 1993 Dec;104(6):1767-9. doi: 10.1378/chest.104.6.1767. |
| 10594267 | Background | Cook CH, Melvin WS, Groner JI, Allen E, King DR. A cost-effective thoracoscopic treatment strategy for pediatric spontaneous pneumothorax. Surg Endosc. 1999 Dec;13(12):1208-10. doi: 10.1007/pl00009622. |
| 7807340 | Background | Poenaru D, Yazbeck S, Murphy S. Primary spontaneous pneumothorax in children. J Pediatr Surg. 1994 Sep;29(9):1183-5. doi: 10.1016/0022-3468(94)90795-1. |
| 17568487 | Background | Butterworth SA, Blair GK, LeBlanc JG, Skarsgard ED. An open and shut case for early VATS treatment of primary spontaneous pneumothorax in children. Can J Surg. 2007 Jun;50(3):171-4. |
| 21482575 | Background | Seguier-Lipszyc E, Elizur A, Klin B, Vaiman M, Lotan G. Management of primary spontaneous pneumothorax in children. Clin Pediatr (Phila). 2011 Sep;50(9):797-802. doi: 10.1177/0009922811404699. Epub 2011 Apr 11. |
| 15868579 | Background | Qureshi FG, Sandulache VC, Richardson W, Ergun O, Ford HR, Hackam DJ. Primary vs delayed surgery for spontaneous pneumothorax in children: which is better? J Pediatr Surg. 2005 Jan;40(1):166-9. doi: 10.1016/j.jpedsurg.2004.09.042. |
| 11171742 | Background | 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 Feb;119(2):590-602. doi: 10.1378/chest.119.2.590. |
| 20696690 | Background | MacDuff A, Arnold A, Harvey J; BTS Pleural Disease Guideline Group. Management of spontaneous pneumothorax: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii18-31. doi: 10.1136/thx.2010.136986. No abstract available. |
| 14577068 | Background | Ozcan C, McGahren ED, Rodgers BM. Thoracoscopic treatment of spontaneous pneumothorax in children. J Pediatr Surg. 2003 Oct;38(10):1459-64. doi: 10.1016/s0022-3468(03)00496-2. |
| 10735663 | Background | Cardillo G, Facciolo F, Giunti R, Gasparri R, Lopergolo M, Orsetti R, Martelli M. Videothoracoscopic treatment of primary spontaneous pneumothorax: a 6-year experience. Ann Thorac Surg. 2000 Feb;69(2):357-61; discussion 361-2. doi: 10.1016/s0003-4975(99)01299-0. |
| 14506122 | Background | Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003 Sep 24;290(12):1624-32. doi: 10.1001/jama.290.12.1624. |