We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 33 of 3257 for:    Louisville

Articulating Enseal Versus Ligasure Energy Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02163538
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 1, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

June 11, 2014
June 13, 2014
June 1, 2016
July 2014
April 2016   (Final data collection date for primary outcome measure)
Raw TLX score [ Time Frame: 18 months ]
This is a validated ergonomic assessment tool used to detect surgeon perception of effort/workload.
SURG-TLX score [ Time Frame: 18 months ]
This is a validated ergonomic assessment tool used to detect surgeon perception of effort/workload.
Complete list of historical versions of study NCT02163538 on ClinicalTrials.gov Archive Site
  • Intra- and post-operative complications [ Time Frame: 18 months ]
  • Time required to complete procedure [ Time Frame: 18 months ]
  • Estimated blood loss [ Time Frame: 18 months ]
  • Cost per hysterectomy [ Time Frame: 18 months ]
  • Need for second energy device intra-operatively [ Time Frame: 18 months ]
  • Length of hospital stay [ Time Frame: 18 months ]
Same as current
Not Provided
Not Provided
 
Articulating Enseal Versus Ligasure Energy Devices
A Comparison of Industry Leading Energy Devices for Use in Gynecologic Laparoscopy: Articulating Enseal Versus Ligasure Energy Devices
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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Task Performance
  • Device: articulating Enseal
    Vessel-sealing device used for laparoscopic hysterectomy.
  • Device: Ligasure device
    Vessel-sealing device used for laparoscopic hysterectomy.
  • Active Comparator: articulating Enseal
    This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.
    Intervention: Device: articulating Enseal
  • Active Comparator: Ligasure device
    This group of women undergoing hysterectomy is randomized to the Ligasure energy device.
    Intervention: Device: Ligasure device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
April 2016
April 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 100 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02163538
Energy Devices-UL
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Data shared with study sponsor, Ethicon, and will be submitted for journal publication.
Resad Pasic, University of Louisville
University of Louisville
Ethicon Endo-Surgery
Principal Investigator: Resad Pasic, MD, PhD University of Louisville
University of Louisville
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP