Single Site Thoracic Surgery for Pediatric Pneumothorax

Thoracic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05034640
• Other study ID #: 5210158
• Status: Completed
• Start date: April 5, 2021
• Est. completion date: April 28, 2021

Study information

• Verified date: February 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Dissection
• Pediatric Disorder
• Pneumothorax
• Pneumothorax, Spontaneous
• Thoracic Diseases
• Thoracic Surgery

Intervention

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.
• 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)

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of opioid doses in 24 hours post-op	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
Primary	Assessment of length of time of chest tube insertion	Time will be recorded from surgery until chest tube removal post operation.	Time from surgery until chest tube removal
Secondary	Assessment of operation time	The length of surgery will be recorded.	The time from surgery incision start to surgery closing will be the end time.
Secondary	Assessment of pneumothorax reoccurrence	If a pneumothorax occurs in the post-operative period, this will be recorded.	Within 48 hours post-operative period after surgery.
Secondary	Total opioid dose from surgery until discharge	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.