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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Surgical Port Site Hernia
Interventions Device: EZ close
Device: Carter Thomason
Enrollment 79
Recruitment Details Eligible patients recruited between July 2017 and June 2018 at St. Vincent's Hospital.
Pre-assignment Details  
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Period Title: Overall Study
Started 40 39
Completed 39 39
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title EZ Close Arm Carter Thomason Arm Total
Hide Arm/Group Description

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Total of all reporting groups
Overall Number of Baseline Participants 39 39 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 39 participants 78 participants
65.3  (10.0) 58.8  (16.2) 62.1  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 78 participants
Female
8
  20.5%
11
  28.2%
19
  24.4%
Male
31
  79.5%
28
  71.8%
59
  75.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 39 participants 39 participants 78 participants
23.2  (2.8) 23.6  (3.1) 23.4  (2.9)
Operation time  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 39 participants 39 participants 78 participants
211.7  (90.0) 217.3  (77.6) 214.5  (83.6)
Operation type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 39 participants 78 participants
Laparoscopic radical nephrectomy
4
  10.3%
6
  15.4%
10
  12.8%
Laparoscopic partial nephrectomy
1
   2.6%
1
   2.6%
2
   2.6%
Laparoscopic radical prostatectomy
4
  10.3%
5
  12.8%
9
  11.5%
Laparoscopic radical cystectomy
2
   5.1%
3
   7.7%
5
   6.4%
Robot-assisted radical nephrectomy
0
   0.0%
1
   2.6%
1
   1.3%
Robot-assisted partial nephrectomy
8
  20.5%
8
  20.5%
16
  20.5%
Robot-assisted radical prostatectomy
16
  41.0%
10
  25.6%
26
  33.3%
Robot-assisted radical cystectomy
2
   5.1%
1
   2.6%
3
   3.8%
Others
2
   5.1%
4
  10.3%
6
   7.7%
1.Primary Outcome
Title Time Taken to Complete Closure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Mean (Standard Deviation)
Unit of Measure: seconds
36.8  (10.1) 48.9  (21.5)
2.Secondary Outcome
Title Number of Participants With Visceral Organ Injury
Hide Description Any inadvertent injury to organs or bleeding during procedure.
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Need for Additional Instrument
Hide Description Need for additional instrument during procedure
Time Frame At the time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
33
  84.6%
4.Secondary Outcome
Title Number of Participants With Port-site Hernia
Hide Description Herniation of bowel segments through port-site
Time Frame 3 days post-op and within one months of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title Number of Participants With Port-site Infection
Hide Description Redness, purulent discharge, tenderness at port-site
Time Frame 3 days post-op and within one months of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.6%
2
   5.1%
6.Secondary Outcome
Title Number of Participants With Ascitic Fluid Leakage
Hide Description Non-infective fluid leakage
Time Frame 3 days post-op and within one months of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Wound Dehiscence
Hide Description Wound dehiscence that required further treatment
Time Frame 3 days post-op and within one months of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description:

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Any adverse events other than the primary and secondary outcome measures were recorded during the study period. (At the time of the surgery, 3-days post-op and within 1 months of operation)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EZ Close Arm Carter Thomason Arm
Hide Arm/Group Description

EZ close used for port-site closure.

EZ close: EZ close used.

Carter Thomason used for port-site closure.

Carter Thomason: Carter Thomason used.

All-Cause Mortality
EZ Close Arm Carter Thomason Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
EZ Close Arm Carter Thomason Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EZ Close Arm Carter Thomason Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)   0/39 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Hee Youn Kim
Organization: St. Vincent's Hospital
Phone: 82-31-249-7473
Responsible Party: Hee Youn Kim, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT03374189     History of Changes
Other Study ID Numbers: EZVSCT
First Submitted: December 11, 2017
First Posted: December 15, 2017
Results First Submitted: September 7, 2018
Results First Posted: February 4, 2019
Last Update Posted: March 1, 2019