Trial Outcomes & Findings for Articulating Enseal Versus Ligasure Energy Devices (NCT NCT02163538)

NCT ID: NCT02163538

Last Updated: 2018-02-13

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2018-02-13

Participant Flow

Participant milestones

Measure	Articulating Enseal 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.	Ligasure Device This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Overall Study STARTED	71	71
Overall Study COMPLETED	70	70
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Articulating Enseal 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.	Ligasure Device This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	0	1

Baseline Characteristics

Articulating Enseal Versus Ligasure Energy Devices

Baseline characteristics by cohort

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.	Total n=140 Participants Total of all reporting groups
Age, Continuous	41.6 years STANDARD_DEVIATION 6.9 • n=5 Participants	41.3 years STANDARD_DEVIATION 7.7 • n=7 Participants	41.4 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	70 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	70 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 18 months

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

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Raw Task Load Index (TLX) Score Assigned by Surgeons	51.7 units on a scale Interval 39.6 to 59.0	32.5 units on a scale Interval 17.7 to 48.1

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Intra- and Post-operative Complications	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Estimated Blood Loss	100 mL Interval 50.0 to 200.0	100 mL Interval 50.0 to 150.0

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Need for Second Energy Device Intra-operatively	10 Participants	0 Participants

SECONDARY outcome

Timeframe: During procedure

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.	35 minutes Interval 25.0 to 48.0	30 minutes Interval 22.0 to 41.0

SECONDARY outcome

Timeframe: End of surgery up to 4 hours

Outcome measures

Measure	Articulating Enseal n=70 Participants 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.	Ligasure Device n=70 Participants This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Time Required to Complete Procedure	97 Minutes Interval 80.0 to 129.0	85 Minutes Interval 69.0 to 120.0

Adverse Events

Articulating Enseal

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Ligasure Device

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Articulating Enseal n=70 participants at risk 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.	Ligasure Device n=70 participants at risk This group of women undergoing hysterectomy is randomized to the Ligasure energy device. Ligasure device: Vessel-sealing device used for laparoscopic hysterectomy.
Blood and lymphatic system disorders blood transfusion	1.4% 1/70 • Number of events 1	1.4% 1/70 • Number of events 1
Injury, poisoning and procedural complications rectal injury	1.4% 1/70 • Number of events 1	0.00% 0/70

Other adverse events

Adverse event data not reported

Additional Information

Dr. Resad Pasic

University Louisville

Phone: 502-561-7465

Email: resad.pasic@louisville.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place