Single Site Thoracic Surgery for Pediatric Pneumothorax

NCT05034640 | Completed

• 1 other identifier: 5210158
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Disorder; Pneumothorax, Spontaneous; Thoracic Diseases; Thoracic Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Assessment of operation time

  The time from surgery incision start to surgery closing will be the end time.

• Assessment of pneumothorax reoccurrence

  Within 48 hours post-operative period after surgery.

• Total opioid dose from surgery until discharge

  Within 72 hours post-operative period after surgery.

Study Arms (2)

Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax

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

Procedure: Conventional multiport thoracoscopic surgery

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

Interventions

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.

Also known as: Video assisted thoracoscopic surgery, multi-incisions

Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax

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)

Also known as: Single incision video assisted thoracoscopic surgery

Single Port Thoracoscopic Surgery for Pediatric Pneumothorax

Eligibility Criteria

• Age: Up to 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• Age \< 19 years old
• pneumothorax
• underwent surgery for pneumothorax

You may not qualify if:

• Age =/\> 19 years old
• history of prior thoracic surgery
• history of cancer

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Related 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.

  PMID: 30418096 BACKGROUND

• 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.

  PMID: 25630836 BACKGROUND

• 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.

  PMID: 30046510 BACKGROUND

• 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.

  PMID: 33395367 BACKGROUND

• 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.

  PMID: 33848830 BACKGROUND

MeSH Terms

Conditions

Pneumothorax; Thoracic Diseases

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Andrei Radulescu, MD, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: September 5, 2021
• Study Start: April 5, 2021
• Primary Completion: April 28, 2021
• Study Completion: April 28, 2021
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The protocol will become available after the study start and for 3 years after the study completion.
• Access Criteria: Pediatric surgeon, request to primary investigator.

Locations

US (1)