Laparoscopic Hysterectomy Clinical Trial
Official title:
Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy
Verified date | August 2014 |
Source | St. Louis University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Saint Louis University | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
St. Louis University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 | A time savings of 6.7 minutes is needed to pay for the cost of the device. | Patients are consented on the day of surgery. Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery. | No |
Secondary | Secondary endpoints will be the number of Participants with complications (vascular and ureteral). | estimated blood loss and complications (vascular and ureteral). | Study patients are monitored for complications for 6 weeks after their surgical procedure. | Yes |
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