Articulating Enseal Versus Ligasure Energy Devices

A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices

This is an exploratory study to assess the ability of the raw-TLX (raw Task Load Index) ergonomic assessment tool to detect differences in surgeon workload when using commercially available advanced bipolar devices. It is anticipated that the raw-TLX version of the validated NASA-TLX ergonomic assessment tool will detect less surgeon effort required in the procedure when articulating ENSEAL is utilized. The Articulating ENSEAL device may also positively impact other variables such as blood loss, operative time and cost.

Study Overview

• Status: Completed
• Conditions: Task Performance
• Intervention / Treatment: Device: articulating Enseal; Device: Ligasure device

Detailed Description

This study is a single-center, single-blinded, randomized control, pilot trial that will be conducted at the University of Louisville Hospital. It is designed to assess whether there are different surgical outcomes with regard to surgeon perception of ease of instrument use, operative time, estimated blood loss, cost and perioperative complication rates between the Ethicon Articulating Enseal versus the LigaSure for total laparoscopic hysterectomy. This will be assessed using the raw-TLX version of the validated NASA-TLX scale.

The study will be single-blinded in that the patient will not be informed of their group assignment; it is impossible to blind the surgeon using the devices.

Methods and Procedures:

Patients undergoing total laparoscopic hysterectomy will be recruited from our University of Louisville Health Care Outpatient Center (HCOC) outpatient office and will be consented for participation in the study during their preoperative office visit.

Patients will be randomized pre-operatively on their date of surgery to one of two groups:

Group 1: The articulating Enseal device will be used during the hysterectomy. Group 2: The Ligasure device will be used during the hysterectomy.

All cases will be videotaped for review of operative time and complications; this is standard procedure at our institution.

To evaluate our primary objective, i.e., the potential ergonomic and surgical advantages of an articulating tip in an energy device, the raw-TLX of the validated NASA-TLX scale will be completed by the primary surgeon at the end of each surgery.

Subjects will be seen for study follow-up during their routine post-operative visits at 2 weeks, 6 weeks and within 3 months after surgery in the event of a hospital admission for a surgery-related complication.

No compensation for participation will be offered to patients and no compensation for subject recruitment will be gained by investigators. This will be disclosed during the informed consent process.

Inclusion Criteria:

• Age 18 or older
• Able and willing to provide informed consent
• Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• Under 18 years of age
• Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
• Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon
• Intra-operative decision to convert to laparotomy prior to use of energy device
• Current diagnosis of uterine, tubal ovarian or cervical malignancy.
• Patients who cannot read/understand English.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Hospital
    • Louisville, Kentucky, United States, 40202
      • University of Louisville Health Care Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Age 18 or older
• Able and willing to provide informed consent
• Undergoing total laparoscopic hysterectomy

Exclusion Criteria:

• Under 18 years of age
• Severe endometriosis or adhesions requiring >15min of adhesiolysis prior to beginning hysterectomy
• Unsafe to use energy device due to decreased visualization or any other reason deemed to be unsafe by the surgeon intra-operative decision to convert to laparotomy prior to use of energy device
• Current diagnosis of uterine, tubal ovarian or cervical malignancy.
• Patients who cannot read/understand English.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: articulating Enseal; This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.	Device: articulating Enseal; Vessel-sealing device used for laparoscopic hysterectomy.
ACTIVE_COMPARATOR: Ligasure device; This group of women undergoing hysterectomy is randomized to the Ligasure energy device.	Device: Ligasure device; Vessel-sealing device used for laparoscopic hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raw Task Load Index (TLX) Score Assigned by Surgeons	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	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Intra- and Post-operative Complications	18 months
Estimated Blood Loss	18 months
Need for Second Energy Device Intra-operatively	18 months
Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.	During procedure
Time Required to Complete Procedure	End of surgery up to 4 hours

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Ethicon Endo-Surgery

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): April 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 12, 2014
• First Posted (ESTIMATE): June 13, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: hysterectomy; laparoscopic; energy device; enseal; ligasure; raw tlx
• Other Study ID Numbers: Energy Devices-UL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data shared with study sponsor, Ethicon, and will be submitted for journal publication.