A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robot

Robotic hysterectomy

Group Type EXPERIMENTAL

Robotic hysterectomy

Intervention Type PROCEDURE

Robotic hysterectomy.

Standard

Standard hysterectomy

Group Type ACTIVE_COMPARATOR

Standard Hysterectomy

Intervention Type PROCEDURE

Standard hysterectomy.

Interventions

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Robotic hysterectomy

Robotic hysterectomy.

Intervention Type PROCEDURE

Standard Hysterectomy

Standard hysterectomy.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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