Disposable Energy Sources and Operating Room Time for Laparoscopic Hysterectomy

NCT02065453 | Completed Results

• 1 other identifier: 22548
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Uterine Disease

Keywords

lap hysterectomy; Women in need of a lap hysterectomy for benign disease.

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Disposable Device - Left & Reusable Devices - Right

OTHER

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

Device: disposable device (Ligasure, Covidien); Device: Reusable device

Disposable Device - Right & Reusable Devices - Left

OTHER

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

Device: disposable device (Ligasure, Covidien); Device: Reusable device

Interventions

disposable device (Ligasure, Covidien) 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.

Also known as: disposable device (Ligasure made by Covidien).

Disposable Device - Left & Reusable Devices - Right; Disposable Device - Right & Reusable Devices - Left

Reusable device DEVICE

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

Also known as: Robi bipolar and Storz laparoscopic

Disposable Device - Left & Reusable Devices - Right; Disposable Device - Right & Reusable Devices - Left

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 to 80 years of age
• Scheduled for laparoscopic hysterectomy (prospectively)

You may not qualify if:

• Under 21 years of age
• Known or anticipated malignancy

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63117, United States

Location

Results Point of Contact

• Title: M. Brigid Holloran-Schwartz, MD
• Organization: Saint Louis University

holloran@slu.edu

314-781-8605

Study Officials

• Mary B Holloran-Schwartz, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 19, 2014
• Study Start: January 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)