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Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

Primary Purpose

Pneumothorax

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Surgery Group
Initial Non-operative management
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Spontaneous Pneumothorax, Video Assisted Thoracoscopic Surgery, Tube Thoracostomy, Pediatric Surgery

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Primary Surgery Group

Initial Non-operative management

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recurrence rate
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Recurrence rate
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Recurrence rate
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Recurrence rate

Secondary Outcome Measures

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)
Hospital Length of stay
Time to return to normal activities
Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department)

Full Information

First Posted
May 12, 2015
Last Updated
November 4, 2019
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02449980
Brief Title
Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax
Official Title
Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Terminated
Why Stopped
DSMB recommended termination on the basis of poor accrual rate. We will transition to a prospective observational (non-randomized) study design.
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
July 26, 2018 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
All children presenting to Texas Children's Hospital with a primary spontaneous pneumothorax will be potentially eligible for the study. 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. Written, informed consent will be obtained by the research nurse coordinator, a pediatric surgical fellow, or an attending pediatric surgeon. Once enrolled, the patients will be randomized to primary surgery: Video-Assisted Thoracoscopic Surgery (VATS), blebectomy and mechanical pleurodesis, versus initial nonoperative treatment. 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. 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. 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. 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. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax
Keywords
Spontaneous Pneumothorax, Video Assisted Thoracoscopic Surgery, Tube Thoracostomy, Pediatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary Surgery Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Initial Non-operative management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Primary Surgery Group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Initial Non-operative management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence rate
Description
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Time Frame
1 month
Title
Recurrence rate
Description
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Time Frame
3 months
Title
Recurrence rate
Description
The recurrence rate is defined as the proportion of patients with recurrent ipsilateral pneumothorax during the follow-up period.
Time Frame
6 months
Title
Recurrence rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Surgical site infection (NSQIP definition), persistent air leak (> 4 days), and prolonged need for chest tube (as quantified by number of chest tube days)
Time Frame
30 days
Title
Hospital Length of stay
Time Frame
1 month
Title
Time to return to normal activities
Time Frame
1 month, 3 months, 6 months, 12 months
Title
Hospital Direct Variable Costs (in US dollars, from hospital cost-accounting department)
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica E Lopez, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Primary Versus Delayed Surgical Therapy for Pediatric Spontaneous Pneumothorax

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