Clinical trial NCT05034640: Single Site Thoracic Surgery for Pediatric Pneumothorax
Official title: Pain Versus Gain: Multiport Versus Single-Port Thoracoscopic Surgery for Pediatric Pneumothorax a Case Series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Disorder
Pneumothorax, Spontaneous
Thoracic Diseases
Thoracic Surgery
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 7
Sex: ALL
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total amount of opioid doses in 24 hours post-op
timeFrame: 24 hours post-operative VATS procedure
measure: Assessment of length of time of chest tube insertion
timeFrame: Time from surgery until chest tube removal
Secondary outcomes:
measure: Assessment of operation time
timeFrame: The time from surgery incision start to surgery closing will be the end time.
measure: Assessment of pneumothorax reoccurrence
timeFrame: Within 48 hours post-operative period after surgery.
measure: Total opioid dose from surgery until discharge
timeFrame: Within 72 hours post-operative period after surgery.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Andrei Radulescu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.