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NCT Number: NCT05034640

Single Site Thoracic Surgery for Pediatric Pneumothorax

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.

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Key information

Conditions

Pediatric Disorder Pleural Diseases Pneumothorax Pneumothorax, Spontaneous Respiratory Tract Diseases Thoracic Diseases Thoracic Surgery

Age range

Up to 19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional multiport thoracoscopic surgery

Procedure

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 site thoracoscopic surgery

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 5, 2021
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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