Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

Pneumothorax Clinical Trial

Official title:

Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02449980
• Other study ID #: H-32402
• Status: Terminated
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: January 31, 2019

Study information

• Verified date: November 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

1. All children presenting to Texas Children's Hospital with a primary spontaneous pneumothorax will be potentially eligible for the study.

2. After the diagnosis has been made and initial medical therapy has been initiated, the patients will be identified and parents or legal guardian approached by the staff surgeon for consent to participate in the study. The attending pediatric surgeon or surgical fellow will discuss the trial with all eligible patients and their families.

3. Written, informed consent will be obtained by the research nurse coordinator, a pediatric surgical fellow, or an attending pediatric surgeon.

4. Once enrolled, the patients will be randomized to primary surgery: Video-Assisted Thoracoscopic Surgery (VATS), blebectomy and mechanical pleurodesis, versus initial nonoperative treatment.

5. Prior to initiating the study, the randomization sequence will be computer-generated by an independent statistician using a permuted block random allocation scheme with a block size of 4,6. The randomization sequence will be maintained securely within the randomization module in REDCap (Research electronic data capture), and it will be accessed only after enrollment has occurred and inclusion criteria are verified by the admitting staff surgeon. The participants and the surgeons will not be blinded to group assignment.

6. Primary Surgery Group. Patients randomized to the primary surgical intervention group will undergo VATS, 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.

7. Initial non-operative management group. 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. "Rescue" VATS/ blebectomy/pleurodesis will be performed in those managed initially nonoperatively who meet criteria for surgery thereafter (i.e. develop a persistent air leak after drainage tube placement). A persistent air leak will be defined as bubbling of air in the Pleur-Evac water chamber upon eliciting positive pressure lasting >4 days, noted and documented in progress note by attending physician. If recurrence is identified in the control group, it will be managed operatively, as per current clinical practice, with VATS/ blebectomy/pleurodesis.

8. Discharge Criteria. Discharge criteria include being afebrile for 24 hours, normal oxygen saturation with no oxygen requirement, benign physical exam, unchanged or improved post-removal chest radiograph, ability to tolerate regular diet and ambulate, and pain well controlled on oral pain medication.

9. Discharge Instructions. A discussion will take place between the surgical team and the family prior to discharge in order to review standardized discharge instructions. These will address an understanding by the patient and family of the signs and symptoms of recurrent pneumothorax as well as specific follow up appointments and the scheduled phone follow-up thereafter. For patients who have had primary surgery, specific postoperative instructions will be given according to current clinical practice.

10. Follow-up. Follow-up will be the same for both groups and will take place at 2-3 weeks after hospital discharge (per standard of care), with subsequent telephone interviews at 3 months, 6 months and 12 months.

11. The primary outcome regarding effectiveness of primary VATS will be the overall recurrence rate at 12 months. Secondary outcomes include surgical complication rate, cumulative hospital length of stay (total number of hospital days during study period), time to resumption of usual activities, and direct variable hospital costs. The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period. Complications to be assessed include surgical site infection, persistent air leak (> 4 days), and prolonged need for chest tube (as quantified by number of chest tube days). Standard National Surgical Quality Improvement Program (NSQIP) definitions of these outcomes will be utilized. The time to resumption of usual activities will be adjudicated at the time of the post-op follow up visit or by means of a phone interview at 2-3 weeks postoperatively. The longest time period to resumption all usual activities will be ascertained from patient questionnaires addressing return to school date, level of pre- and post-illness activity, and daily activity log kept by the patient or their parent. Post-operative quality of life will be assessed at 3 months, 6 months, and 12 months by telephone administration of The PedsQL Measurement Model for the Pediatric Quality of Life Inventory, a widely-used and validated tool.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 31, 2019
• Est. primary completion date: July 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children ages 5 to 18 with clinical diagnosis of primary spontaneous pneumothorax (symptoms of chest pain and/or shortness of breath and pneumothorax demonstrated on chest radiograph) and no prior history of pneumothorax

Exclusion Criteria:

• Blunt or penetrating trauma

• Cystic fibrosis

• Pneumonia

• Uncontrolled asthma with hospitalization for exacerbation within previous 30 days

• Congenital cystic adenomatoid malformation or congenital lobar emphysema

• History of previous cardiac or pulmonary surgery

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Procedure:
• Primary Surgery Group
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
• Initial Non-operative management
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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Donahue DM, Wright CD, Viale G, Mathisen DJ. Resection of pulmonary blebs and pleurodesis for spontaneous pneumothorax. Chest. 1993 Dec;104(6):1767-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

O'Lone E, Elphick HE, Robinson PJ. Spontaneous pneumothorax in children: when is invasive treatment indicated? Pediatr Pulmonol. 2008 Jan;43(1):41-6. — View Citation

Ozcan C, McGahren ED, Rodgers BM. Thoracoscopic treatment of spontaneous pneumothorax in children. J Pediatr Surg. 2003 Oct;38(10):1459-64. — View Citation

Poenaru D, Yazbeck S, Murphy S. Primary spontaneous pneumothorax in children. J Pediatr Surg. 1994 Sep;29(9):1183-5. — View Citation

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. — View Citation

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. Review. — View Citation

Sahn SA, Heffner JE. Spontaneous pneumothorax. N Engl J Med. 2000 Mar 23;342(12):868-74. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate	The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.	1 month
Primary	Recurrence rate	The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.	3 months
Primary	Recurrence rate	The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.	6 months
Primary	Recurrence rate		12 months
Secondary	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
Secondary	Hospital Length of stay		1 month
Secondary	Time to return to normal activities		1 month, 3 months, 6 months, 12 months
Secondary	Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department)		1 month