Skip to main content
OpenTrials
Completed

NCT Number: NCT03374189

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Port Site Hernia

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent's Hospital

Suwon, 16247, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EZ close

Device

EZ close used.

Carter Thomason

Device

Carter Thomason used.

Primary outcomes

  1. Time Taken to Complete Closure

    Time frame: At the time of surgery

    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.

Secondary outcomes

  1. Number of Participants With Visceral Organ Injury

    Time frame: At the time of surgery

    Any inadvertent injury to organs or bleeding during procedure.

  2. Number of Participants With Need for Additional Instrument

    Time frame: At the time of surgery

    Need for additional instrument during procedure

  3. Number of Participants With Port-site Hernia

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

    Herniation of bowel segments through port-site

  4. Number of Participants With Port-site Infection

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

    Redness, purulent discharge, tenderness at port-site

  5. Number of Participants With Ascitic Fluid Leakage

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

    Non-infective fluid leakage

  6. Number of Participants With Wound Dehiscence

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

    Wound dehiscence that required further treatment

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2017
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.