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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Operating Time
Time frame: Operating time is measured on the day of surgery after completing the procedure.
Estimated Blood Loss
Time frame: Estimated blood loss will be measured on the day of surgery after completing the procedure.
Intraoperative Complications
Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage
Time frame: Intraoperative complications will be measured on the day of surgery after completing the procedure.
Perioperative Complications
Perioperative complications include: urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE)
Time frame: Perioperative complications will be measured on the date of discharge from the hospital.
Early Postoperative Complications
Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)
Time frame: Early postoperative complications will be measured on the date of discharge from the hospital until two weeks after surgery, assessed up to 14 days post-operativley.
Delayed Post-Operative Complications
Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration
Time frame: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
Costs
Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.
Time frame: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.
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