Study Stopped
Lack of funding
A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy
Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
June 28, 2013
CompletedJune 28, 2013
May 1, 2013
3.9 years
May 6, 2009
May 9, 2013
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Procedure Time - Skin Incision to Skin Closure
At skin closure.
Study Arms (2)
Robot
EXPERIMENTALRobotic hysterectomy
Standard
ACTIVE COMPARATORStandard hysterectomy
Interventions
Eligibility Criteria
You may qualify if:
- \- All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.
You may not qualify if:
- \- Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Scottsdale, Arizona, 85253, United States
Limitations and Caveats
The study was terminated due to lack of funding.
Results Point of Contact
- Title
- Dr. Rosanne Kho
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Rosanne Kho, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
March 1, 2007
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
June 28, 2013
Results First Posted
June 28, 2013
Record last verified: 2013-05