Articulating Enseal Versus Ligasure Energy Devices

Task Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163538
• Other study ID #: Energy Devices-UL
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: January 17, 2018
• Start date: July 2014
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Task Performance

Intervention

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

Locations

Country	Name	City	State
United States	University of Louisville Health Care Outpatient Center	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

Outcome

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