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

Saint Vincent's Hospital, Korea79 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Surgical Port Site Hernia

Interventions

EZ closeDEVICE

EZ close used.

Carter ThomasonDEVICE

Carter Thomason used.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Vincent's Hospital

Suwon, South Korea

Outcomes

Primary Outcomes

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.

Time frame: At the time of surgery

Secondary Outcomes

Number of Participants With Visceral Organ Injury

Any inadvertent injury to organs or bleeding during procedure.

Time frame: At the time of surgery

Number of Participants With Need for Additional Instrument

Need for additional instrument during procedure

Time frame: At the time of surgery

Number of Participants With Port-site Hernia

Herniation of bowel segments through port-site

Time frame: 3 days post-op and within one months of surgery

Number of Participants With Port-site Infection

Redness, purulent discharge, tenderness at port-site

Time frame: 3 days post-op and within one months of surgery

Number of Participants With Ascitic Fluid Leakage

Non-infective fluid leakage

Time frame: 3 days post-op and within one months of surgery

Number of Participants With Wound Dehiscence

Wound dehiscence that required further treatment

Time frame: 3 days post-op and within one months of surgery

Data from ClinicalTrials.gov

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