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

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 Overview

• Status: Completed
• Conditions: Surgical Port Site Hernia
• Intervention / Treatment: Device: EZ close; Device: Carter Thomason

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16247
    • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EZ Close arm; EZ close used for port-site closure.	Device: EZ close; EZ close used.
ACTIVE_COMPARATOR: Carter Thomason arm; Carter Thomason used for port-site closure.	Device: Carter Thomason; Carter Thomason used.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Investigators: Principal Investigator: Hee Youn Kim, St Vincent's Hospital

Publications and helpful links

General Publications

• del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device. J Endourol. 2014 Jul;28(7):814-8. doi: 10.1089/end.2014.0069. Epub 2014 Apr 23.
• Shetty A, Adiyat KT. Comparison between hand suture and Carter-Thomason needle closure of port sites in laparoscopy. Urol J. 2014 Sep 2;11(4):1768-71.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2017
• Primary Completion (ACTUAL): May 9, 2018
• Study Completion (ACTUAL): May 24, 2018

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (ACTUAL): December 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: EZVSCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No