N/A
N=52
Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy
Benign Uterine Disease
Bottom Line
View on ClinicalTrials.gov: NCT02065453 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side — 8.4; 14.6 minutes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- disposable device (Ligasure, Covidien) (Device); Reusable device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- St. Louis University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint of This Study is Time Difference Between Cauterizing One Side of the Uterine Attachments, From the Round Ligament to the Uterine Artery on One Side, to the Time Detaching the Same Tissues on the Other Side |
8.4; 14.6 | <0.001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Age 21 to 80 years of age
- Scheduled for laparoscopic hysterectomy (prospectively)
Exclusion Criteria
- Under 21 years of age
- Known or anticipated malignancy
Data sourced from ClinicalTrials.gov (NCT02065453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.