Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy
Condition: Benign Uterine Disease
MeSH terms: Uterine Diseases
Study type: Interventional

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.
    

Detailed description: 
      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 laparoscopic 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.
    

Intervention name(s): disposable device (Ligasure, Covidien); Reusable device
Intervention type(s): Device; Device
Intervention description(s): 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.; One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic
Other intervention name(s): disposable device (Ligasure made by Covidien).; Robi bipolar and Storz laparoscopic
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lap hysterectomy; Women in need of a lap hysterectomy for benign disease.