NCT02163538

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed
Last Updated

February 13, 2018

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

June 11, 2014

Results QC Date

April 25, 2017

Last Update Submit

January 17, 2018

Conditions

Task Performance

Keywords

energy devicelaparoscopichysterectomyensealligasureraw tlx

Outcome Measures

Primary Outcomes (1)

  • Raw Task Load Index (TLX) Score Assigned by Surgeons

    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

    18 months

Secondary Outcomes (5)

  • Intra- and Post-operative Complications

    18 months

  • Estimated Blood Loss

    18 months

  • Need for Second Energy Device Intra-operatively

    18 months

  • Time From Port Placement to Bilateral Uterine Artery Ligation and Hemostatsis.

    During procedure

  • Time Required to Complete Procedure

    End of surgery up to 4 hours

Study Arms (2)

articulating Enseal

ACTIVE COMPARATOR

This group of women undergoing total laparoscopic hysterectomy is randomized to the the articulating Enseal energy device.

Device: articulating Enseal

Ligasure device

ACTIVE COMPARATOR

This group of women undergoing hysterectomy is randomized to the Ligasure energy device.

Device: Ligasure device

Interventions

articulating EnsealDEVICE

Vessel-sealing device used for laparoscopic hysterectomy.

articulating Enseal
Ligasure deviceDEVICE

Vessel-sealing device used for laparoscopic hysterectomy.

Ligasure device

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Able and willing to provide informed consent
  • Undergoing total laparoscopic hysterectomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Louisville Health Care Outpatient Center

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Results Point of Contact

Title
Dr. Resad Pasic
Organization
University Louisville
resad.pasic@louisville.edu
502-561-7465

Study Officials

  • Resad Pasic, MD, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor with Tenure of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 13, 2014

Study Start

July 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 13, 2018

Results First Posted

January 17, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Data shared with study sponsor, Ethicon, and will be submitted for journal publication.

Locations

US(2)