Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

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.

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