Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device

Conditions
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Surgical Port Site Hernia

Intervention / Treatment
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* Device: EZ close
* Device: Carter Thomason


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with laparoscopic ports over 10mm Exclusion Criteria: Patients with laparoscopic ports under 10mm Patients who refused the study Patients who received concurrent surgery for other reason

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EZ Close arm<br>EZ close used for port-site closure. | Device: EZ close<br>* EZ close used.<br>|
| Active Comparator: Carter Thomason arm<br>Carter Thomason used for port-site closure. | Device: Carter Thomason<br>* Carter Thomason used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |