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.

Study Overview

• Status: Completed
• Conditions: Benign Uterine Disease
• Intervention / Treatment: Device: disposable device (Ligasure, Covidien); Device: Reusable 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Disposable Device - Left & Reusable Devices - Right; One side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien).	Device: disposable device (Ligasure, Covidien); 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.; Other Names: disposable device (Ligasure made by Covidien).; Device: Reusable device; One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic; Other Names: Robi bipolar and Storz laparoscopic
OTHER: Disposable Device - Right & Reusable Devices - Left; One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic	Device: disposable device (Ligasure, Covidien); 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.; Other Names: disposable device (Ligasure made by Covidien).; Device: Reusable device; One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic; Other Names: Robi bipolar and Storz laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	duration of surgery	Primary outcome study data is collected with the first incision and completed with skin closure at the completion of the surgery.

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Mary B Holloran-Schwartz, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: February 11, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (ESTIMATE): February 19, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 14, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: lap hysterectomy; Women in need of a lap hysterectomy for benign disease.
• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: 22548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data