Single Site Thoracic Surgery for Pediatric Pneumothorax

Sponsor
Loma Linda University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05034640
Collaborator
(none)
20
1
27.9
0.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Conventional multiport thoracoscopic surgery
  • Procedure: Single port site thoracoscopic surgery

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 Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Pain Versus Gain: Multiport Versus Single-Port Thoracoscopic Surgery for Pediatric Pneumothorax a Case Series
Actual Study Start Date :
Apr 5, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm 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 MiniĀ® port (Applied Medical, Rancho Santa Margarita, California, USA)
    Other Names:
  • Single incision video assisted thoracoscopic surgery
  • Outcome Measures

    Primary Outcome Measures

    1. Total amount of opioid doses in 24 hours post-op [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 from surgery until chest tube removal]

      Time will be recorded from surgery until chest tube removal post operation.

    Secondary Outcome Measures

    1. Assessment of operation time [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 19 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Loma Linda California United States 92350

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

    • Principal Investigator: Andrei Radulescu, MD, PhD, Loma Linda University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT05034640
    Other Study ID Numbers:
    • 5210158
    First Posted:
    Sep 5, 2021
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2022