Pediatric DisorderNCT05034640
Single Site Thoracic Surgery for Pediatric Pneumothorax
An observational study of Pediatric Disorder and Pneumothorax, Spontaneous, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Pediatric Disorder, Pneumothorax, Spontaneous, Thoracic Diseases
- What is being tested?
- Conventional multiport thoracoscopic surgery and Single port site thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 28 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Age < 19 years old
- pneumothorax
- underwent surgery for pneumothorax
Who cannot join
- Age =/> 19 years old
- history of prior thoracic surgery
- history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Versus Gain: Multiport Versus Single-Port Thoracoscopic Surgery for Pediatric Pneumothorax a Case Series
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.
Read the 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.
- Being tested
- Conventional multiport thoracoscopic surgery, Single port site thoracoscopic surgery
- Medical subject headings
- Pneumothorax, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional multiport thoracoscopic surgeryProcedure or surgery
Also called Video assisted thoracoscopic surgery, multi-incisions
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 surgeryProcedure or surgery
Also called Single incision video assisted 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)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax | Patients who had multiport video assisted thoracoscopic surgery for pediatric pneumothorax. Receives: Procedure: Conventional multiport thoracoscopic surgery | |
| Single Port Thoracoscopic Surgery for Pediatric Pneumothorax | Patients who had single port video assisted thoracoscopic surgery for pediatric pneumothorax. Receives: Procedure: Single port site thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time from surgery until chest tube removal
Secondary outcomes (3)
Assessment of operation time
The length of surgery will be recorded.
Measured: The time from surgery incision start to surgery closing will be the end time.
Assessment of pneumothorax reoccurrence
If a pneumothorax occurs in the post-operative period, this will be recorded.
Measured: Within 48 hours post-operative period after surgery.
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.
Measured: Within 72 hours post-operative period after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start5 Apr 2021
- Primary completion28 Apr 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrei Radulescu, MD, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034640
- Sponsor's protocol ID
- 5210158
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2021
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol and data will be shared amongst study staff.
Publications
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.
PubMed 30418096Song 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.
PubMed 25630836Martynov 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.
PubMed 30046510Zimmermann 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.
PubMed 33395367Goodman 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.
PubMed 33848830
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Versus Gain: Multiport Versus Single-Port Thoracoscopic Surgery for Pediatric Pneumothorax a Case Series
- ClinicalTrials.gov ID
- NCT05034640
- Acronym / sponsor ID
- 5210158
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax | – | Procedure: Conventional multiport thoracoscopic surgeryPatients who had multiport video assisted thoracoscopic surgery for pediatric pneumothorax. |
| Single Port Thoracoscopic Surgery for Pediatric Pneumothorax | – | Procedure: Single port site thoracoscopic surgeryPatients who had single port video assisted thoracoscopic surgery for pediatric pneumothorax. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Age < 19 years old
- pneumothorax
- underwent surgery for pneumothorax
Key exclusion criteria (3 listed)
- Age =/> 19 years old
- history of prior thoracic surgery
- history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional multiport thoracoscopic surgeryAlso: Video assisted thoracoscopic surgery, multi-incisionsUse 2 or more incisions for multiple instrument entry during the surgery and chest tube placement at the end of the operation. | Procedure or surgery | Conventional Multiport Thoracoscopic Surgery for Pediatric Pneumothorax |
| Single port site thoracoscopic surgeryAlso: Single incision video assisted thoracoscopic surgeryUsing 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) | Procedure or surgery | Single Port Thoracoscopic Surgery for Pediatric Pneumothorax |
Primary outcome
Total amount of opioid doses in 24 hours post-op
Time frame: 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.
Assessment of length of time of chest tube insertion
Time frame: Time from surgery until chest tube removal
Time will be recorded from surgery until chest tube removal post operation.
3 secondary outcomes
Assessment of operation time
Time frame: The time from surgery incision start to surgery closing will be the end time.
Assessment of pneumothorax reoccurrence
Time frame: Within 48 hours post-operative period after surgery.
Total opioid dose from surgery until discharge
Time frame: Within 72 hours post-operative period after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 30418096Fernandez-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.
- Background: PubMed 25630836Song 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.
- Background: PubMed 30046510Martynov 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.
- Background: PubMed 33395367Zimmermann 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.
- Background: PubMed 33848830Goodman 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.
- Individual participant dataSharing planned: Yes. The protocol and data will be shared amongst study staff.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Radulescu, MD, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Disorder and Pneumothorax, Spontaneous, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of opioid doses in 24 hours post-op (time frame: 24 hours post-operative VATS procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05034640, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.