NCT03433209

Brief Summary

The effect of two different bipolar instruments were compared in terms of operative time, total operative time, intra-operative blood loss and intra-operative and postoperative complications. Devices included the LigaSure™ Maryland Jaw 5 mm laparoscopic instrument (LigaSure; LF 1737, Covidien, Mansfield, MA, USA) and ENSEAL™ G2 Articulating Straight 5mm Tissue Sealer (ENSEAL; NSLG2S35A, Ethicon Endo-surgery, US, LLC).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

Study Start

First participant enrolled

June 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
Last Updated

February 15, 2018

Status Verified

February 1, 2018

Enrollment Period

1.5 years

First QC Date

February 8, 2018

Last Update Submit

February 14, 2018

Conditions

Task Performance

Keywords

Advanced bipolar energy devicesENSEALLigaSureOperative timeTotal laparoscopic hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Operative time

    Defined as time from start of sealing and transection of the round ligament until start of colpotomy, was the primary endpoint.

    16 months

Secondary Outcomes (3)

  • Total operative time

    16 months

  • Intra-operative estimated blood loss

    16 months

  • Intra-operative complications

    16 months

Study Arms (2)

Ligasure device

ACTIVE COMPARATOR

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

Device: Ligasure device

Articulating Enseal

ACTIVE COMPARATOR

This group of women undergoing hysterectomy were randomized to the articulating Enseal energy device

Device: Articulating Enseal

Interventions

Ligasure deviceDEVICE

Vessel-sealing device used for laparoscopic hysterectomy

Ligasure device
Articulating EnsealDEVICE

Vessel-sealing device used for laparoscopic hysterectomy

Articulating Enseal

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
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
  • Suspected malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 14, 2018

Study Start

June 1, 2016

Primary Completion

November 30, 2017

Study Completion

February 2, 2018

Last Updated

February 15, 2018

Record last verified: 2018-02