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

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

Loma Linda University

Investigators

  • 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)

April 5, 2021

Primary Completion (Actual)

April 28, 2021

Study Completion (Actual)

April 28, 2021

Study Registration Dates

First Submitted

August 17, 2021

First Submitted That Met QC Criteria

August 29, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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