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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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ClinicalTrials.gov Identifier: NCT03374189
Recruitment Status : Completed
First Posted : December 15, 2017
Results First Posted : February 4, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hee Youn Kim, 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.

Condition or disease Intervention/treatment Phase
Surgical Port Site Hernia Device: EZ close Device: Carter Thomason Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
Actual Study Start Date : August 17, 2017
Actual Primary Completion Date : May 9, 2018
Actual Study Completion Date : May 24, 2018

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374189


Locations
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Korea, Republic of
St. Vincent's Hospital
Suwon, Korea, Republic of, 16247
Sponsors and Collaborators
Saint Vincent's Hospital, Korea
Investigators
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Principal Investigator: Hee Youn Kim St. Vincent's Hospital-Manhattan
  Study Documents (Full-Text)

Documents provided by Hee Youn Kim, Saint Vincent's Hospital, Korea:

Publications:
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Responsible Party: Hee Youn Kim, Assistant Professor, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT03374189     History of Changes
Other Study ID Numbers: EZVSCT
First Posted: December 15, 2017    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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