Articulating Enseal Versus Ligasure Energy Devices

NCT ID: NCT02163538

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-04-30

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.

Conditions

Task Performance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

articulating Enseal

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

Group Type: ACTIVE_COMPARATOR

articulating Enseal

Intervention Type: DEVICE

Vessel-sealing device used for laparoscopic hysterectomy.

Ligasure device

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

Group Type: ACTIVE_COMPARATOR

Ligasure device

Intervention Type: DEVICE

Vessel-sealing device used for laparoscopic hysterectomy.

Interventions

articulating Enseal

Vessel-sealing device used for laparoscopic hysterectomy.

Intervention Type: DEVICE

Ligasure device

Vessel-sealing device used for laparoscopic hysterectomy.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Resad Pasic

Professor with Tenure of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Resad Pasic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville Health Care Outpatient Center

Louisville, Kentucky, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

Energy Devices-UL

Identifier Type: -

Identifier Source: org_study_id