A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

May 9, 2013 updated by: Mayo Clinic

Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial

Robotic technology has been used for laparoscopic hysterectomies for over 10 years. Mayo Clinic Arizona has used robotics in Gynecology for the last 10 years with well over 500 procedures performed. Similar to the laparoscopic approach, small incisions are utilized with the robotic approach. Robotic instruments differ from laparoscopic instruments in that the tips of the instruments can rotate more like the human wrist. The instruments are attached to the robotic arms which are controlled by your surgeon. The surgeon is seated at the surgeon's console which is located 12 feet from the patient while the surgical assistant is at your bedside assisting in the procedure.

This study is being done to compare the procedure times and results after laparoscopic hysterectomies to laparoscopic hysterectomies performed with robotic assistance.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85253
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.

Exclusion Criteria:

- Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robot
Robotic hysterectomy
Procedure: Robotic hysterectomy
Robotic hysterectomy.
Active Comparator: Standard
Standard hysterectomy
Procedure: Standard Hysterectomy
Standard hysterectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total Procedure Time - Skin Incision to Skin Closure
Time Frame: At skin closure.
At skin closure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Rosanne Kho, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Estimate)

June 28, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 06-008892

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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