Single Site Thoracic Surgery for Pediatric Pneumothorax

February 13, 2024 updated by: Loma Linda University

Pain Versus Gain: Multiport Versus Single-Port Thoracoscopic Surgery for Pediatric Pneumothorax a Case Series

Video-Assisted Thoracoscopic Surgery (VATS) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. There are limitations for working in children. The site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. We propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

While Video-Assisted Thoracoscopic Surgery (VATS) has become a standard of care in adults, pediatric surgeons have been slower to undertake this approach. The limitations for working in children are decreased working space, unknown thoracoscopic effects on body physiology, and instrument accommodation. Especially as the field for minimally invasive surgery expands, using the single port approach has unique implications in children. The site of a chest tube becomes the working site for thoracoscopic surgery and the only scar. Despite some learning curve, the preliminary outcomes are similar to the multiport surgeries with better cosmesis. The learning curves for single port site surgery have been well described and our group recently performed a similar study for appendectomies. We propose this study to do a retrospective review comparing the conventional multiport thoracic surgery with the newer single port site.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

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
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients (age <19 years old) who presented to our hospital for the treatment of pneumothorax. Some patients were transferred from outside facilities, but did not have prior thoracic surgery or history of cancer.

Description

Inclusion Criteria:

  • Age < 19 years old
  • pneumothorax
  • underwent surgery for pneumothorax

Exclusion Criteria:

  • Age =/> 19 years old
  • history of prior thoracic surgery
  • history of cancer

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax
Patients who had multiport video assisted thoracoscopic surgery for pediatric pneumothorax.
Procedure: Conventional multiport thoracoscopic surgery
Use 2 or more incisions for multiple instrument entry during the surgery and chest tube placement at the end of the operation.
Other Names:
  • Video assisted thoracoscopic surgery, multi-incisions
Single Port Thoracoscopic Surgery for Pediatric Pneumothorax
Patients who had single port video assisted thoracoscopic surgery for pediatric pneumothorax.
Procedure: Single port site thoracoscopic surgery
Using only 1 incision for multiple instrument entry during the surgery and chest tube placement at the end of the operation. Single port - GelPOINT Mini® port (Applied Medical, Rancho Santa Margarita, California, USA)
Other Names:
  • Single incision video assisted thoracoscopic surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total amount of opioid doses in 24 hours post-op
Time Frame: 24 hours post-operative VATS procedure
Pain medication records will be reviewed for all opioids dispensed during the post-operative period until time of discharge. The name of the opioid, the dosage, the route, and the frequency will be recorded.period until time of discharge. The name of the opioid, the dosage, the route, and the frequency will be recorded.
24 hours post-operative VATS procedure
Assessment of length of time of chest tube insertion
Time Frame: Time from surgery until chest tube removal
Time will be recorded from surgery until chest tube removal post operation.
Time from surgery until chest tube removal

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of operation time
Time Frame: The time from surgery incision start to surgery closing will be the end time.
The length of surgery will be recorded.
The time from surgery incision start to surgery closing will be the end time.
Assessment of pneumothorax reoccurrence
Time Frame: Within 48 hours post-operative period after surgery.
If a pneumothorax occurs in the post-operative period, this will be recorded.
Within 48 hours post-operative period after surgery.
Total opioid dose from surgery until discharge
Time Frame: Within 72 hours post-operative period after surgery.
Pain medication records will be reviewed for all opioids dispensed during the period from start of surgery through time of hospital discharge. The name of the opioid, the dosage, the route, and the frequency will be recorded.
Within 72 hours post-operative period after surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Loma Linda University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrei Radulescu, MD, PhD, Loma Linda University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5210158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The protocol and data will be shared amongst study staff.

IPD Sharing Time Frame

The protocol will become available after the study start and for 3 years after the study completion.

IPD Sharing Access Criteria

Pediatric surgeon, request to primary investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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