Hysterectomy
Conditions
Keywords
robotic, laparoscopic surgical procedures
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.
Interventions
PROCEDURERobotic hysterectomy
Robotic hysterectomy.
PROCEDUREStandard Hysterectomy
Standard hysterectomy.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Procedure Time - Skin Incision to Skin Closure | At skin closure. |
Countries
United States
Participant flow
Recruitment details
All subjects were recruited at Mayo Clinic in Arizona.
Participants by arm
| Arm | Count |
|---|---|
| Robot Robotic hysterectomy | 3 |
| Standard Standard hysterectomy | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Robot | Total |
|---|---|---|
| Age Categorical <=18 years | 0 participants | 0 participants |
| Age Categorical >=65 years | 0 participants | 0 participants |
| Age Categorical Between 18 and 65 years | 3 participants | 3 participants |
| Gender Female | 3 participants | 3 participants |
| Gender Male | 0 participants | 0 participants |
| Region of Enrollment United States | 3 participants | 3 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
Primary
Total Procedure Time - Skin Incision to Skin Closure
Time frame: At skin closure.
Population: The study was terminated due to lack of funding; due to the small sample size, no analysis was done.