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A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

This study has been terminated.
(Lack of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00895284
First Posted: May 8, 2009
Last Update Posted: June 28, 2013
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.
Information provided by:
Mayo Clinic
  Purpose

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 Intervention Phase
Hysterectomy Procedure: Robotic hysterectomy Procedure: Standard Hysterectomy Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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

Enrollment: 3
Study Start Date: March 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot
Robotic hysterectomy
Procedure: Robotic hysterectomy
Robotic hysterectomy.
Active Comparator: Standard
Standard hysterectomy
Procedure: Standard Hysterectomy
Standard hysterectomy.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00895284


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

Responsible Party: Rosanne Kho MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00895284     History of Changes
Other Study ID Numbers: 06-008892
First Submitted: May 6, 2009
First Posted: May 8, 2009
Results First Submitted: May 9, 2013
Results First Posted: June 28, 2013
Last Update Posted: June 28, 2013
Last Verified: May 2013

Keywords provided by Mayo Clinic:
robotic
laparoscopic surgical procedures