A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00895284
First received: May 6, 2009
Last updated: May 9, 2013
Last verified: May 2013
  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
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:


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 ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Results First Received: May 9, 2013
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
robotic
laparoscopic surgical procedures

ClinicalTrials.gov processed this record on October 20, 2014