Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

NCT ID: NCT02065453

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

Brief 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.

Conditions

Benign Uterine Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Disposable Device - Left & Reusable Devices - Right

One side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien).

Group Type: OTHER

disposable device (Ligasure, Covidien)

Intervention Type: DEVICE

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.

Reusable device

Intervention Type: DEVICE

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic

Disposable Device - Right & Reusable Devices - Left

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic

Group Type: OTHER

disposable device (Ligasure, Covidien)

Intervention Type: DEVICE

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.

Reusable device

Intervention Type: DEVICE

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic

Interventions

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.

Intervention Type: DEVICE

Reusable device

One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic

Intervention Type: DEVICE

Other Intervention Names

disposable device (Ligasure made by Covidien).; Robi bipolar and Storz laparoscopic

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Louis University

OTHER

Sponsor Role: lead

Responsible Party

Mary Brigid Holloran-Schwartz, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary B Holloran-Schwartz, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

Saint Louis University

St Louis, Missouri, United States

Countries

United States

Other Identifiers

22548

Identifier Type: -

Identifier Source: org_study_id