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

Saint Vincent's Hospital, Korea

Status: Completed

Conditions: Surgical Port Site Hernia

Treatments: Device: Carter Thomason; Device: EZ close

Study type: Interventional

Funder types: Other

Identifiers

NCT03374189

EZVSCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

EZ Close arm

Experimental group

Description:

EZ close used for port-site closure.

Treatment:

Device: EZ close

Carter Thomason arm

Active Comparator group

Description:

Carter Thomason used for port-site closure.

Treatment:

Device: Carter Thomason