A Trial on Laparoscopic Hysterectomy Versus Robotic Hysterectomy

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Hysterectomy

Treatments: Procedure: Robotic hysterectomy; Procedure: Standard Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00895284

06-008892

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Robot

Experimental group

Description:

Robotic hysterectomy

Treatment:

Procedure: Robotic hysterectomy

Standard

Active Comparator group

Description:

Standard hysterectomy

Treatment:

Procedure: Standard Hysterectomy