Articulating Enseal Versus Ligasure Energy Devices

Completed · Not applicable

Conditions studied: Task Performance

In brief

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.

Key facts

Study ID

NCT02163538

Run by

University of Louisville

People needed

142

Starts

2014-07-01

Expected to finish

2016-04-01

Last updated by the study team

2018-02-13

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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