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

Not Applicable

Completed

• Conditions: Surgical Port Site Hernia
• Interventions: Device: EZ close; Device: Carter Thomason

• Registration Number: NCT03374189
• Lead Sponsor: Saint Vincent's Hospital, Korea

Brief 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.

Study Timeline

• Study Start: 2017-08-17
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-15
• Primary Completion: 2018-05-09
• Study Completion: 2018-05-24
• Results First Submitted: 2018-09-07
• Results First Submitted QC: 2018-09-07
• Status Verified: 2019-02
• Results First Posted: 2019-02-04
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EZ Close arm	EZ close	EZ close used for port-site closure.
Carter Thomason arm	Carter Thomason	Carter Thomason used for port-site closure.

Primary Outcome Measures

Name	Time	Method
Time Taken to Complete Closure	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 Outcome Measures

Name	Time	Method
Number of Participants With Visceral Organ Injury	At the time of surgery	Any inadvertent injury to organs or bleeding during procedure.
Number of Participants With Need for Additional Instrument	At the time of surgery	Need for additional instrument during procedure
Number of Participants With Port-site Hernia	3 days post-op and within one months of surgery	Herniation of bowel segments through port-site
Number of Participants With Port-site Infection	3 days post-op and within one months of surgery	Redness, purulent discharge, tenderness at port-site
Number of Participants With Ascitic Fluid Leakage	3 days post-op and within one months of surgery	Non-infective fluid leakage
Number of Participants With Wound Dehiscence	3 days post-op and within one months of surgery	Wound dehiscence that required further treatment

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of