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A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

This study is currently recruiting participants.
Verified April 2013 by Mayo Clinic
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00895284
First received: May 6, 2009
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is aimed to compare the standard laparoscopic approach to the hysterectomy with the robotic approach. The time it takes to perform the procedure, blood loss, complications during the surgery and 6 weeks after surgery will be evaluated.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • total procedure time - skin incision to skin closure [ Time Frame: At skin closure. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: March 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895284

Contacts
Contact: Beth Gleason 480-342-3007 gleason.elizabeth@mayo.edu

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85253
Contact: Kristina A Butler, MD     623-376-7712     butler.kristina@mayo.edu    
Principal Investigator: Rosanne M Kho, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Rosanne Kho, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Rosanne Kho MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00895284     History of Changes
Other Study ID Numbers: 06-008892
Study First Received: May 6, 2009
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
robotic
laparoscopic surgical procedures

ClinicalTrials.gov processed this record on May 22, 2013