N/A
N=142
Articulating Enseal Versus Ligasure Energy Devices
Task Performance
Bottom Line
View on ClinicalTrials.gov: NCT02163538 ↗Enrolled (actual)
142
Serious AEs
2.1%
Results posted
Jan 2018
Primary outcome: Primary: Raw Task Load Index (TLX) Score Assigned by Surgeons — 51.7; 32.5 units on a scale — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- articulating Enseal (Device); Ligasure device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Louisville
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Raw Task Load Index (TLX) Score Assigned by Surgeons |
51.7; 32.5 | 0.0001 sig |
| SECONDARY Intra- and Post-operative Complications |
1; 2 | 1.00 |
| SECONDARY Estimated Blood Loss |
100; 100 | 0.582 |
| SECONDARY Need for Second Energy Device Intra-operatively |
10; 0 | 0.0031 sig |
| SECONDARY Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis. |
35; 30 | 0.0281 sig |
| SECONDARY Time Required to Complete Procedure |
97; 85 | .0821 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02163538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.