Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

Laparoscopic Hysterectomy Clinical Trial

Official title:

Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065453
• Other study ID #: 22548
• Status: Completed
• Phase: N/A
• First received: February 11, 2014
• Last updated: August 26, 2014
• Start date: January 2012
• Est. completion date: January 2014

Study information

• 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

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Disease
• Laparoscopic Hysterectomy

Intervention

Device:
• disposable device (Ligasure, Covidien), and the reusable devices,(Robi bipolar and Storz laparoscopic shears).
Each patient serve as their own control where one side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien), and the other using the reusable Robi bipolar and Storz laparoscopic shears. 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.

Locations

Country	Name	City	State
United States	Saint Louis University	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

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