Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 80
Updated:4/2/2016
Start Date:March 2012
End Date:June 2013
Contact:Janis L Green, MD
Email:jgreen3@hmc.psu.edu
Phone:717-531-6447

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A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution

Approximately 600,000 women undergo hysterectomy each year in the United States, of which
12% are laparoscopic. The most common indications for hysterectomy are: symptomatic uterine
leiomyomas (40.7%), endometriosis (17.7%), and prolapse (14.5%). The first total
laparoscopic hysterectomy was performed by Reich et al in 1988. Many studies have proven
that laparoscopic hysterectomy is associated with lower preoperative morbidity, shorter
hospital stay, and shorter recovery times than abdominal hysterectomy. The literature has
also shown the complication rates for laparoscopic cases are similar to open procedures in
the hands of an experienced laparoscopic surgeon. The American Congress of Obstetricians and
Gynecologists Committee on Gynecologic Practice state that laparoscopic hysterectomy is an
alternative to abdominal hysterectomy for those patients in whom vaginal hysterectomy is not
indicated or feasible. The ACOG Committee on Gynecologic Practice site multiple advantages
of laparoscopic hysterectomy to abdominal hysterectomy including faster recovery, shorter
hospital stay, less blood loss, and fewer abdominal wall/wound infections. Despite the
recommendations of ACOG for a more minimally invasive approach, 66% of all hysterectomies
are performed abdominally. Key reasons for the lag in utilization of laparoscopic techniques
are the technical obstacles of performing minimally invasive hysterectomies. Robotic
technology has emerged as a means to decrease the learning curve and increase the
availability of minimally invasive surgery to patients. A current review of the literature
reveals no randomized trials evaluating the efficacy of conventional laparoscopic
hysterectomy vs. robot-assisted laparoscopic hysterectomy. The investigator's aim is to
address this void.

The primary objective of this study is to determine whether Robot-Assisted Laparoscopic
Hysterectomy is equivalent to Conventional Laparoscopic Hysterectomy with respect to
operative time, blood loss, and hospital stay. The investigator's secondary objective was to
assess the cost, morbidity, and mortality of each procedure.

See Above

Inclusion Criteria:

- Individuals recruited into this study will be patients presenting to the
Urogynecology and Minimally Invasive Surgical Group for consultation for
hysterectomy.

Exclusion Criteria:Individuals who are not candidates for laparoscopic surgery

- Medical Condition that does not allow pneumoperitoneum

- Medical Condition that does not allow proper ventilation during anesthesia

- Uterine size precluding access to the uterine artery

- Pelvic Organ Prolapse amendable to a vaginal approach
We found this trial at
1
site
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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mi
from
Hershey, PA
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