Surgical Port Site HerniaNCT03374189
Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
A study testing EZ close and Carter Thomason in people with Surgical Port Site Hernia, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
Trial summary
This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Surgical Port Site Hernia
- What is being tested?
- EZ close and Carter Thomason
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2017to 24 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with laparoscopic ports over 10mm
Who cannot join
- Patients with laparoscopic ports under 10mm
- Patients who refused the study
- Patients who received concurrent surgery for other reason
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
Read the detailed description
Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
- Conditions
- Surgical Port Site Hernia
- Being tested
- EZ close, Carter Thomason
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ closeDevice
EZ close used.
Carter ThomasonDevice
Carter Thomason used.
| Study group | Role | What they receive |
|---|---|---|
| EZ Close arm | Experimental | EZ close used for port-site closure. Receives: Device: EZ close |
| Carter Thomason arm | Active comparator | Carter Thomason used for port-site closure. Receives: Device: Carter Thomason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Taken to Complete Closure
The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.
Measured: At the time of surgery
Secondary outcomes (6)
Number of Participants With Visceral Organ Injury
Any inadvertent injury to organs or bleeding during procedure.
Measured: At the time of surgery
Number of Participants With Need for Additional Instrument
Need for additional instrument during procedure
Measured: At the time of surgery
Number of Participants With Port-site Hernia
Herniation of bowel segments through port-site
Measured: 3 days post-op and within one months of surgery
Number of Participants With Port-site Infection
Redness, purulent discharge, tenderness at port-site
Measured: 3 days post-op and within one months of surgery
Number of Participants With Ascitic Fluid Leakage
Non-infective fluid leakage
Measured: 3 days post-op and within one months of surgery
Number of Participants With Wound Dehiscence
Wound dehiscence that required further treatment
Measured: 3 days post-op and within one months of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start17 Aug 2017
- Primary completion9 May 2018
- Study completion24 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical Port Site HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Vincent's Hospital, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee Youn Kim, Saint Vincent's Hospital, Korea
- Investigators
- Hee Youn Kim, Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374189
- Sponsor's protocol ID
- EZVSCT
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2017
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device. J Endourol. 2014 Jul;28(7):814-8. doi: 10.1089/end.2014.0069. Epub 2014 Apr 23.
PubMed 24588556Shetty A, Adiyat KT. Comparison between hand suture and Carter-Thomason needle closure of port sites in laparoscopy. Urol J. 2014 Sep 2;11(4):1768-71.
PubMed 25194073
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
- ClinicalTrials.gov ID
- NCT03374189
- Acronym / sponsor ID
- EZVSCT
- Conditions
- Surgical Port Site Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Saint Vincent's Hospital, KoreaUniversity, hospital or other
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 24 May 2018 (actual)
- First posted
- 15 Dec 2017 (actual)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
Detailed description
Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EZ Close arm | Experimental | Device: EZ closeEZ close used for port-site closure. |
| Carter Thomason arm | Active comparator | Device: Carter ThomasonCarter Thomason used for port-site closure. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with laparoscopic ports over 10mm
Key exclusion criteria (3 listed)
- Patients with laparoscopic ports under 10mm
- Patients who refused the study
- Patients who received concurrent surgery for other reason
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 |
|---|---|---|
| EZ closeEZ close used. | Device | EZ Close arm |
| Carter ThomasonCarter Thomason used. | Device | Carter Thomason arm |
Primary outcome
Time Taken to Complete Closure
Time frame: At the time of surgery
The start of the procedure was defined as the point when the device was first inserted through the port-site and the end of the procedure was defined as the point when the port-site was removed from the port-site. A stopwatch was used to measure the time.
6 secondary outcomes
Number of Participants With Visceral Organ Injury
Time frame: At the time of surgery
Number of Participants With Need for Additional Instrument
Time frame: At the time of surgery
Number of Participants With Port-site Hernia
Time frame: 3 days post-op and within one months of surgery
Number of Participants With Port-site Infection
Time frame: 3 days post-op and within one months of surgery
Number of Participants With Ascitic Fluid Leakage
Time frame: 3 days post-op and within one months of surgery
Number of Participants With Wound Dehiscence
Time frame: 3 days post-op and within one months of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24588556del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device. J Endourol. 2014 Jul;28(7):814-8. doi: 10.1089/end.2014.0069. Epub 2014 Apr 23.
- Background: PubMed 25194073Shetty A, Adiyat KT. Comparison between hand suture and Carter-Thomason needle closure of port sites in laparoscopy. Urol J. 2014 Sep 2;11(4):1768-71.
- Individual participant dataSharing planned: No
Related trials for Surgical Port Site Hernia
Recruiting
Robotic Single Port Ventral Hernia Repair
Ventral Hernia Repair
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.
Hee Youn Kim principal investigator
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZ close and Carter Thomason in people with Surgical Port Site Hernia, run by Saint Vincent's Hospital, Korea at 1 site in South Korea.
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 1 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 1 Mar 2019. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time Taken to Complete Closure (time frame: At the time of surgery). 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 NCT03374189, which also lists 2 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 1 Mar 2019.