Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

November 4, 2019 updated by: Monica Esperanza Lopez, Baylor College of Medicine

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Primary Surgery Group
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.
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
ACTIVE_COMPARATOR: Initial Non-operative management
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 12 months
12 months
Recurrence rate
Time Frame: 1 month
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
1 month
Recurrence rate
Time Frame: 3 months
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
3 months
Recurrence rate
Time Frame: 6 months
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days
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
Time Frame: 1 month
1 month
Time to return to normal activities
Time Frame: 1 month, 3 months, 6 months, 12 months
1 month, 3 months, 6 months, 12 months
Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department)
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Investigators

  • Principal Investigator: Monica E Lopez, MD, Baylor College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 5, 2017

Primary Completion (ACTUAL)

July 26, 2018

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (ESTIMATE)

May 21, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-32402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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