Articulating Enseal Versus Ligasure Energy Devices
Condition: Task Performance
Study type: Interventional

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.
    

Intervention name(s): articulating Enseal; Ligasure device
Intervention type(s): Device; Device
Intervention description(s): Vessel-sealing device used for laparoscopic hysterectomy.; Vessel-sealing device used for laparoscopic hysterectomy.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: energy device; laparoscopic; hysterectomy; enseal; ligasure; raw tlx