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

Primary Purpose

Surgical Port Site Hernia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EZ close
Carter Thomason
Sponsored by
Saint Vincent's Hospital, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Port Site Hernia

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • St. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EZ Close arm

Carter Thomason arm

Arm Description

EZ close used for port-site closure.

Carter Thomason used for port-site closure.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants With Visceral Organ Injury
Any inadvertent injury to organs or bleeding during procedure.
Number of Participants With Need for Additional Instrument
Need for additional instrument during procedure
Number of Participants With Port-site Hernia
Herniation of bowel segments through port-site
Number of Participants With Port-site Infection
Redness, purulent discharge, tenderness at port-site
Number of Participants With Ascitic Fluid Leakage
Non-infective fluid leakage
Number of Participants With Wound Dehiscence
Wound dehiscence that required further treatment

Full Information

First Posted
December 11, 2017
Last Updated
February 13, 2019
Sponsor
Saint Vincent's Hospital, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03374189
Brief Title
Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
Official Title
Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
May 9, 2018 (Actual)
Study Completion Date
May 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Vincent's Hospital, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Port Site Hernia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EZ Close arm
Arm Type
Experimental
Arm Description
EZ close used for port-site closure.
Arm Title
Carter Thomason arm
Arm Type
Active Comparator
Arm Description
Carter Thomason used for port-site closure.
Intervention Type
Device
Intervention Name(s)
EZ close
Intervention Description
EZ close used.
Intervention Type
Device
Intervention Name(s)
Carter Thomason
Intervention Description
Carter Thomason used.
Primary Outcome Measure Information:
Title
Time Taken to Complete Closure
Description
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 Outcome Measure Information:
Title
Number of Participants With Visceral Organ Injury
Description
Any inadvertent injury to organs or bleeding during procedure.
Time Frame
At the time of surgery
Title
Number of Participants With Need for Additional Instrument
Description
Need for additional instrument during procedure
Time Frame
At the time of surgery
Title
Number of Participants With Port-site Hernia
Description
Herniation of bowel segments through port-site
Time Frame
3 days post-op and within one months of surgery
Title
Number of Participants With Port-site Infection
Description
Redness, purulent discharge, tenderness at port-site
Time Frame
3 days post-op and within one months of surgery
Title
Number of Participants With Ascitic Fluid Leakage
Description
Non-infective fluid leakage
Time Frame
3 days post-op and within one months of surgery
Title
Number of Participants With Wound Dehiscence
Description
Wound dehiscence that required further treatment
Time Frame
3 days post-op and within one months of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hee Youn Kim
Organizational Affiliation
St Vincent's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24588556
Citation
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.
Results Reference
background
PubMed Identifier
25194073
Citation
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.
Results Reference
background

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

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