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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZ Close arm | Experimental | EZ close used for port-site closure. |
|
| Carter Thomason arm | Active Comparator | Carter Thomason used for port-site closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZ close | Device | EZ close used. |
| |
| Carter Thomason |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Visceral Organ Injury | Any inadvertent injury to organs or bleeding during procedure. | At the time of surgery |
| Number of Participants With Need for Additional Instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Youn Kim | St Vincent's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Suwon | 16247 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24588556 | Background | 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. | |
| 25194073 | Background | Shetty 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. |
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Eligible patients recruited between July 2017 and June 2018 at St. Vincent's Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | EZ Close Arm | EZ close used for port-site closure. EZ close: EZ close used. |
| FG001 | Carter Thomason Arm | Carter Thomason used for port-site closure. Carter Thomason: Carter Thomason used. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EZ Close Arm | EZ close used for port-site closure. EZ close: EZ close used. |
| BG001 | Carter Thomason Arm | Carter Thomason used for port-site closure. Carter Thomason: Carter Thomason used. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | seconds | At the time of surgery |
|
Any adverse events other than the primary and secondary outcome measures were recorded during the study period. (At the time of the surgery, 3-days post-op and within 1 months of operation)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EZ Close Arm | EZ close used for port-site closure. EZ close: EZ close used. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hee Youn Kim | St. Vincent's Hospital | 82-31-249-7473 | khyoun10589@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2017 | Sep 7, 2018 | Prot_SAP_000.pdf |
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| Device |
Carter Thomason used. |
|
Need for additional instrument during procedure
| At the time of surgery |
| Number of Participants With Port-site Hernia | Herniation of bowel segments through port-site | 3 days post-op and within one months of surgery |
| Number of Participants With Port-site Infection | Redness, purulent discharge, tenderness at port-site | 3 days post-op and within one months of surgery |
| Number of Participants With Ascitic Fluid Leakage | Non-infective fluid leakage | 3 days post-op and within one months of surgery |
| Number of Participants With Wound Dehiscence | Wound dehiscence that required further treatment | 3 days post-op and within one months of surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Operation time | Mean | Standard Deviation | minutes |
|
| Operation type | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Visceral Organ Injury | Any inadvertent injury to organs or bleeding during procedure. | Posted | Count of Participants | Participants | At the time of surgery |
|
|
|
| Secondary | Number of Participants With Need for Additional Instrument | Need for additional instrument during procedure | Posted | Count of Participants | Participants | At the time of surgery |
|
|
|
| Secondary | Number of Participants With Port-site Hernia | Herniation of bowel segments through port-site | Posted | Count of Participants | Participants | 3 days post-op and within one months of surgery |
|
|
|
| Secondary | Number of Participants With Port-site Infection | Redness, purulent discharge, tenderness at port-site | Posted | Count of Participants | Participants | 3 days post-op and within one months of surgery |
|
|
|
| Secondary | Number of Participants With Ascitic Fluid Leakage | Non-infective fluid leakage | Posted | Count of Participants | Participants | 3 days post-op and within one months of surgery |
|
|
|
| Secondary | Number of Participants With Wound Dehiscence | Wound dehiscence that required further treatment | Posted | Count of Participants | Participants | 3 days post-op and within one months of surgery |
|
|
|
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Carter Thomason Arm | Carter Thomason used for port-site closure. Carter Thomason: Carter Thomason used. | 0 | 39 | 0 | 39 | 0 | 39 |
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| Laparoscopic radical prostatectomy |
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| Laparoscopic radical cystectomy |
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| Robot-assisted radical nephrectomy |
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| Robot-assisted partial nephrectomy |
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| Robot-assisted radical prostatectomy |
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| Robot-assisted radical cystectomy |
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| Others |
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