Clinical trial NCT02163538: Articulating Enseal Versus Ligasure Energy Devices
Official title: A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Task Performance
Keywords: energy device
laparoscopic
hysterectomy
enseal
ligasure
raw tlx
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2014-06-13
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

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.

Primary outcomes:
measure: Raw Task Load Index (TLX) Score Assigned by Surgeons
timeFrame: 18 months
Secondary outcomes:
measure: Intra- and Post-operative Complications
timeFrame: 18 months
measure: Estimated Blood Loss
timeFrame: 18 months
measure: Need for Second Energy Device Intra-operatively
timeFrame: 18 months
measure: Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.
timeFrame: During procedure
measure: Time Required to Complete Procedure
timeFrame: End of surgery up to 4 hours
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Health Care Outpatient Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Resad Pasic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: