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Articulating Enseal Versus Ligasure Energy Devices

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ClinicalTrials.gov Identifier: NCT02163538
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 17, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Resad Pasic, University of Louisville

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Other
Condition Task Performance
Interventions Device: articulating Enseal
Device: Ligasure device
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Period Title: Overall Study
Started 71 71
Completed 70 70
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             0
Physician Decision             0             1
Arm/Group Title Articulating Enseal Ligasure Device Total
Hide Arm/Group Description

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Total of all reporting groups
Overall Number of Baseline Participants 70 70 140
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 70 participants 140 participants
41.6  (6.9) 41.3  (7.7) 41.4  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 70 participants 140 participants
Female
70
 100.0%
70
 100.0%
140
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 70 participants 70 participants 140 participants
70 70 140
1.Primary Outcome
Title Raw Task Load Index (TLX) Score Assigned by Surgeons
Hide Description

The Official NASA Task Load Index (TLX) is a subjective workload assessment tool to allow users to perform subjective workload assessments on operator(s) working with various human-machine interface systems. By incorporating a multi-dimensional rating procedure, NASA TLX derives an overall workload score based on a weighted average of ratings on six subscales given below. The overall workload score ranges between 0 and 100 with 100 being the most demanding.

Mental Demand Physical Demand Temporal Demand Performance Effort Frustration

Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
51.7
(39.6 to 59.0)
32.5
(17.7 to 48.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Intra- and Post-operative Complications
Hide Description [Not Specified]
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.4%
2
   2.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Estimated Blood Loss
Hide Description [Not Specified]
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Median (Inter-Quartile Range)
Unit of Measure: mL
100
(50 to 200)
100
(50 to 150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.582
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Need for Second Energy Device Intra-operatively
Hide Description [Not Specified]
Time Frame 18 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Measure Type: Count of Participants
Unit of Measure: Participants
10
  14.3%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
Hide Description [Not Specified]
Time Frame During procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Median (Inter-Quartile Range)
Unit of Measure: minutes
35
(25 to 48)
30
(22 to 41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0281
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Time Required to Complete Procedure
Hide Description [Not Specified]
Time Frame End of surgery up to 4 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description:

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

Overall Number of Participants Analyzed 70 70
Median (Inter-Quartile Range)
Unit of Measure: Minutes
97
(80 to 129)
85
(69 to 120)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Articulating Enseal, Ligasure Device
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0821
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Articulating Enseal Ligasure Device
Hide Arm/Group Description

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

articulating Enseal: Vessel-sealing device used for laparoscopic hysterectomy.

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.

All-Cause Mortality
Articulating Enseal Ligasure Device
Affected / at Risk (%) Affected / at Risk (%)
Total   0/70 (0.00%)      0/70 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Articulating Enseal Ligasure Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/70 (2.86%)      1/70 (1.43%)    
Blood and lymphatic system disorders     
blood transfusion   1/70 (1.43%)  1 1/70 (1.43%)  1
Injury, poisoning and procedural complications     
rectal injury   1/70 (1.43%)  1 0/70 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Articulating Enseal Ligasure Device
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/70 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Resad Pasic
Organization: University Louisville
Phone: 502-561-7465
Responsible Party: Resad Pasic, University of Louisville
ClinicalTrials.gov Identifier: NCT02163538     History of Changes
Other Study ID Numbers: Energy Devices-UL
First Submitted: June 11, 2014
First Posted: June 13, 2014
Results First Submitted: April 25, 2017
Results First Posted: January 17, 2018
Last Update Posted: February 13, 2018