A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Hysterectomy Clinical Trial

Official title:

Laparoscopic Hysterectomy With and Without Robotic Assistance: a Randomized Prospective Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00895284
• Other study ID #: 06-008892
• Status: Terminated
• Phase: Phase 4
• First received: May 6, 2009
• Last updated: May 9, 2013
• Start date: March 2007
• Est. completion date: February 2011

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Procedure:
• Robotic hysterectomy
Robotic hysterectomy.
• Standard Hysterectomy
Standard hysterectomy.

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Procedure Time - Skin Incision to Skin Closure		At skin closure.	No