Laparoscopic Hysterectomy Clinical Trial
Official title:
Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy
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.
This will be a randomized, prospective study. The investigators study design would have each
patient serve as their own control. One side of the uterine attachments would be transected
using the disposable device, Ligasure (Covidien), and the other using the two reusable
devices (Robi bipolar and Storz laparoscpic shears). It is the investigators standard
practice that the attending surgeon is on the patient's left side while the resident
physician is on the patients right. To eliminate the bias of surgical experience, the
investigators will randomize the energy source used on each side for every case. Therefore,
the number of cases performed by the attending surgeon with the disposable or reusable
energy sources, will equal that of the less experienced resident surgeon.
The primary endpoint of this study would be the 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. The vesico-uterine peritoneum or
"bladder flap", will always be transected from the left for consistency. Sealed, opaque
envelopes will be randomized to determine which side of the uterus will get the single
disposable instrument, and which will get the 2 reusable instruments.
A time savings of 6.7 minutes for the total case can also be explained by a 3.35 minute time
savings PER SIDE of the uterine attachments, given each uterus has two "sides". There is no
pre-existing data on time needed for coagulation and cutting of the vascular tissues. Based
on experience, the investigators estimate that it takes on average about 20 min total time
for vessel sealing, with an estimated variability that approximately 70% of the time, vessel
sealing is done within 35 minutes. Given these estimates, and using a power of 0.8, the
sample size needed is 45.
The primary endpoint of surgical time will be initially assessed for each individual patient
by determining the difference between the half of the laparoscopic hysterectomy procedure
performed with the disposable device, specifically the Ligasure (Covidien) and the half of
the laparoscopic hysterectomy procedure performed with the two reusable devices (Robi
Bipolar and Storz laparoscopic shears) and determining if the mean difference score summed
across all patients differs significantly from zero. Subsequent analyses will examine
surgical times for attending physicians and residents separately where those using the
disposable device are compared to those using the two reusable devices with independent
students t test or the Kolmogorov-Smirnov test depending on the normality of the
distributions. Parallel analyses will be performed for the secondary endpoint of estimated
blood loss. Secondary endpoints of organ damage and other categorical intraoperative
complications will be compared between the disposable and reusable device groups using
chi-square and Fisher's Exact test.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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