A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Phase 4

Terminated

• Conditions: Hysterectomy
• Interventions: Procedure: Robotic hysterectomy; Procedure: Standard Hysterectomy

• Registration Number: NCT00895284
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2013-05
• Results First Submitted: 2013-05-09
• Results First Submitted QC: 2013-05-09
• Last Update Submitted: 2013-05-09
• Results First Posted: 2013-06-28
• Last Update Posted: 2013-06-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• All subjects eligible for a laparoscopic hysterectomy with or without bilateral salpingo-oophorectomy, and with or without appendectomy will be recruited.

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Exclusion Criteria

• Patients with malignant disease, pregnancy, gynecologic infection, or requiring procedure on an emergent basis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot	Robotic hysterectomy	Robotic hysterectomy
Standard	Standard Hysterectomy	Standard hysterectomy

Primary Outcome Measures

Name	Time	Method
Total Procedure Time - Skin Incision to Skin Closure	At skin closure.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States