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Trial record 40 of 3400 for:    Louisville

Articulating Enseal Versus Ligasure Energy Devices

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ClinicalTrials.gov Identifier: NCT02163538
Recruitment Status : Completed
First Posted : June 13, 2014
Results First Posted : January 17, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Resad Pasic, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Task Performance Device: articulating Enseal Device: Ligasure device Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
Study Start Date : July 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: articulating Enseal
This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.
Device: articulating Enseal
Vessel-sealing device used for laparoscopic hysterectomy.

Active Comparator: Ligasure device
This group of women undergoing hysterectomy is randomized to the Ligasure energy device.
Device: Ligasure device
Vessel-sealing device used for laparoscopic hysterectomy.




Primary Outcome Measures :
  1. Raw Task Load Index (TLX) Score Assigned by Surgeons [ Time Frame: 18 months ]

    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



Secondary Outcome Measures :
  1. Intra- and Post-operative Complications [ Time Frame: 18 months ]
  2. Estimated Blood Loss [ Time Frame: 18 months ]
  3. Need for Second Energy Device Intra-operatively [ Time Frame: 18 months ]
  4. Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis. [ Time Frame: During procedure ]
  5. Time Required to Complete Procedure [ Time Frame: End of surgery up to 4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163538


Locations
United States, Kentucky
University of Louisville Health Care Outpatient Center
Louisville, Kentucky, United States, 40202
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Ethicon Endo-Surgery
Investigators
Principal Investigator: Resad Pasic, MD, PhD University of Louisville

Responsible Party: Resad Pasic, Professor with Tenure of Obstetrics and Gynecology, University of Louisville
ClinicalTrials.gov Identifier: NCT02163538     History of Changes
Other Study ID Numbers: Energy Devices-UL
First Posted: June 13, 2014    Key Record Dates
Results First Posted: January 17, 2018
Last Update Posted: February 13, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data shared with study sponsor, Ethicon, and will be submitted for journal publication.

Keywords provided by Resad Pasic, University of Louisville:
energy device
laparoscopic
hysterectomy
enseal
ligasure
raw tlx