Trial Information

A Prospective Randomized Trial Comparing Conventional vs. Robotic Assisted Laparoscopic Hysterectomy

Compared to abdominal hysterectomy, the advantages of laparoscopic hysterectomy are
decreased postoperative intravenous analgesia requirements, shorter length of hospital stay,
quicker return to work and daily activities. Longer operating times have been shown to be
offset by shorter hospital stays, with similar hospital costs overall. Compared to abdominal
hysterectomy, laparoscopic hysterectomy is associated with less blood loss, fewer abdominal
wall infections, or febrile episodes. The increased visualization allows for concomitant
evaluation and excision of adhesions or endometriosis, as well as facilitating oophorectomy.

Robotic systems were developed in order to facilitate laparoscopy by more ergonomic
movements that are easier to perform and more precise. The da Vinci Surgical System
(Intuitive Surgical Inc., Sunnyvale, CA, USA) has endowrist instruments that have seven
degrees of movement and mimic the human wrist. It can also filter out tremors and other
unintentional hand motions that may result from prolonged holding of instruments. The
surgeon seated at a console commands the laparoscope and two laparoscopic surgical
instruments.

In the literature, several case series have described the use of robotic-assisted
hysterectomy. Two of these series included patients that were undergoing surgery for
suspected malignancy, and hence has a different patient population that we are going to
enroll.Overall these studies have demonstrated the feasibility of using robot-enhanced
technology in order to perform hysterectomy in series of approximately 10-20 patients, with
a similar rate of complications compared to classical laparoscopy.

The objective of this study is to conduct a prospective randomized controlled trial of
robotic assisted versus traditional hysterectomy in the treatment of patients who have
benign indications for hysterectomy, e.g. menorrhagia, symptomatic fibroid uteri, etc. Our
primary outcome is operative time from incision to either closure or, in the case of
concomitant prolapse or incontinence procedures, the completion of the hysterectomy portion
of the case, i.e. closure of vaginal cuff and achievement of hemostasis from the
hysterectomy. Secondary outcomes include intra-operative, peri-operative, and post-operative
complications; post-operative patient outcomes as measured by the Short Form 36 (SF-36)
questionnaire. Patient scores on this questionnaire before and after surgery can be used to
calculate the quality adjusted life years (QALYs), which can then be used in the cost
utility analysis. Patients' overall narcotic use and quality of life will also be assessed
after surgery with diaries at different intervals. The diaries will consist of a daily
narcotic/pain medication diary, a weekly assessment of return to normal activity, and
assessments at 2, 4, and 6 weeks of surgical pain and ability to perform functional
activities.