A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00895284
Recruitment Status : Terminated (Lack of funding)
First Posted : May 8, 2009
Results First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Information provided by:
Mayo Clinic

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hysterectomy Procedure: Robotic hysterectomy Procedure: Standard Hysterectomy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial
Study Start Date : March 2007
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Experimental: Robot
Robotic hysterectomy
Procedure: Robotic hysterectomy
Robotic hysterectomy.

Active Comparator: Standard
Standard hysterectomy
Procedure: Standard Hysterectomy
Standard hysterectomy.

Primary Outcome Measures :
  1. Total Procedure Time - Skin Incision to Skin Closure [ Time Frame: At skin closure. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00895284

United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85253
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Rosanne Kho, MD Mayo Clinic

Responsible Party: Rosanne Kho MD, Mayo Clinic Identifier: NCT00895284     History of Changes
Other Study ID Numbers: 06-008892
First Posted: May 8, 2009    Key Record Dates
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013
Last Verified: May 2013

Keywords provided by Mayo Clinic:
laparoscopic surgical procedures