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Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

NCT02065453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-06-14

Study results available
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Summary

Over 600,000 hysterectomies are performed each year nationwide. Over 99% of these are accomplished laparoscopically in the investigators current surgical practice to allow women a quicker recovery than a traditional large incision. Disposable laparoscopic devices have been developed to assist in the completion of hysterectomies. These disposable energy sources are only used once, but offer an improved safety and energy profile in that they reliably control bleeding with little damage to surrounding tissue and potentially save time. Reusable energy instruments can be sterilized and reused for multiple cases. Operating room time is expensive. The investigators calculate that if 6.7 minutes of time can be saved using the disposable device, Ligasure (Covidien), versus the reusable Robi bipolar and Storz Laparoscopic Shears, the time savings could justify the cost of the device.

Conditions

  • Benign Uterine Disease

Interventions

DEVICE

disposable device (Ligasure, Covidien)

One side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien). . We will randomize the side for each energy source used on each side for every case. The number of "sides" performed by the attending surgeon will equal that of the less experienced resident surgeon.

DEVICE

Reusable device

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic

Sponsors & Collaborators

  • St. Louis University

    lead OTHER

Principal Investigators

  • Mary B Holloran-Schwartz, MD · St. Louis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02065453 on ClinicalTrials.gov