Single Site Thoracic Surgery for Pediatric Pneumothorax

NCT ID: NCT05034640

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-05

Study Completion Date

2021-04-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediatric Disorder Pneumothorax, Spontaneous Thoracic Diseases Thoracic Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax

Patients who had multiport video assisted thoracoscopic surgery for pediatric pneumothorax.

Conventional multiport thoracoscopic surgery

Intervention Type PROCEDURE

Use 2 or more incisions for multiple instrument entry during the surgery and chest tube placement at the end of the operation.

Single Port Thoracoscopic Surgery for Pediatric Pneumothorax

Patients who had single port video assisted thoracoscopic surgery for pediatric pneumothorax.

Single port site thoracoscopic surgery

Intervention Type 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 MiniĀ® port (Applied Medical, Rancho Santa Margarita, California, USA)

Interventions

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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.

Intervention Type 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)

Intervention Type PROCEDURE

Other Intervention Names

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Video assisted thoracoscopic surgery, multi-incisions Single incision video assisted thoracoscopic surgery

Eligibility Criteria

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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
Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrei Radulescu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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Loma Linda University

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Fernandez-Pineda I, Seims AD, VanHouwelingen L, Abdelhafeez H, Wu H, Wu J, Murphy AJ, Davidoff AM. Modified Uniportal Video-Assisted Thoracic Surgery Versus Three-Port Approach for Lung Nodule Biopsy in Pediatric Cancer Patients. J Laparoendosc Adv Surg Tech A. 2019 Mar;29(3):409-414. doi: 10.1089/lap.2018.0120. Epub 2018 Nov 10.

Reference Type BACKGROUND
PMID: 30418096 (View on PubMed)

Song IH, Lee SY, Lee SJ. Can single-incision thoracoscopic surgery using a wound protector be used as a first-line approach for the surgical treatment of primary spontaneous pneumothorax? A comparison with three-port video-assisted thoracoscopic surgery. Gen Thorac Cardiovasc Surg. 2015 May;63(5):284-9. doi: 10.1007/s11748-015-0522-2. Epub 2015 Jan 29.

Reference Type BACKGROUND
PMID: 25630836 (View on PubMed)

Martynov I, Lacher M. Homemade Glove Port for Single-Incision Pediatric Endosurgery (SIPES) Appendectomy-How We Do It. European J Pediatr Surg Rep. 2018 Jan;6(1):e56-e58. doi: 10.1055/s-0038-1667140. Epub 2018 Jul 24.

Reference Type BACKGROUND
PMID: 30046510 (View on PubMed)

Zimmermann P, Martynov I, Perger L, Scholz S, Lacher M. 20 Years of Single-Incision-Pediatric-Endoscopic-Surgery: A Survey on Opinion and Experience Among International Pediatric Endosurgery Group Members. J Laparoendosc Adv Surg Tech A. 2021 Mar;31(3):348-354. doi: 10.1089/lap.2020.0797. Epub 2020 Dec 31.

Reference Type BACKGROUND
PMID: 33395367 (View on PubMed)

Goodman LF, Lin AC, Sacks MA, McRae JJLH, Radulescu A, Khan FA. Single site versus conventional laparoscopic appendectomy: some pain for no gain? J Surg Res. 2021 Aug;264:321-326. doi: 10.1016/j.jss.2021.03.010. Epub 2021 Apr 10.

Reference Type BACKGROUND
PMID: 33848830 (View on PubMed)

Other Identifiers

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5210158

Identifier Type: -

Identifier Source: org_study_id

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