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Primary Surgery Group for Primary Spontaneous Pneumothorax

N/A
Waitlist Available
Led By Monica E Lopez, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Primary Spontaneous Pneumothorax
  • Collapsed Lung

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence rate
Secondary study objectives
Postoperative complications

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Primary Surgery GroupActive Control1 Intervention
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.
Group II: Initial Non-operative managementActive Control1 Intervention
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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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,022 Previous Clinical Trials
6,029,309 Total Patients Enrolled
Monica E Lopez, MDPrincipal InvestigatorBaylor College of Medicine
~0 spots leftby Oct 2025
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