NCT03374189

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Saint Vincent's Hospital, Korea · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	EZ close	EZ close used.
DEVICE	Carter Thomason	Carter Thomason used.

Timeline

• Start date: 2017-08-17
• Primary completion: 2018-05-09
• Completion: 2018-05-24
• First posted: 2017-12-15
• Last updated: 2019-03-01
• Results posted: 2019-02-04

Locations

1 site across 1 country: South Korea