Clinical trial NCT01581905: Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
Official title: A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Menorrhagia
Dysfunctional Uterine Bleeding
Leiomyoma
Pelvic Pain
Endometriosis
Keywords: Hysterectomy
Laparoscopy
Robotics
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: See Above

Eligibility criteria: 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

Primary outcomes:
measure: Operating Time
timeFrame: Operating time is measured on the day of surgery after completing the procedure.
Secondary outcomes:
measure: Estimated Blood Loss
timeFrame: Estimated blood loss will be measured on the day of surgery after completing the procedure.
measure: Intraoperative Complications
timeFrame: Intraoperative complications will be measured on the day of surgery after completing the procedure.
measure: Perioperative Complications
timeFrame: Perioperative complications will be measured on the date of discharge from the hospital.
measure: Early Postoperative Complications
timeFrame: 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.
measure: Delayed Post-Operative Complications
timeFrame: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively.
measure: Costs
timeFrame: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Janis L Green, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Milton S. Hershey Medical Center
name: Gerald J Harkins, MD
role: STUDY_DIRECTOR
affiliation: Milton S. Hershey Medical Center
name: Matthew Davies, MD
role: STUDY_CHAIR
References:
citation: Sarlos D, Kots LA. Robotic versus laparoscopic hysterectomy: a review of recent comparative studies. Curr Opin Obstet Gynecol. 2011 Aug;23(4):283-8. doi: 10.1097/GCO.0b013e328348a26e.
citation: Pasic RP, Rizzo JA, Fang H, Ross S, Moore M, Gunnarsson C. Comparing robot-assisted with conventional laparoscopic hysterectomy: impact on cost and clinical outcomes. J Minim Invasive Gynecol. 2010 Nov-Dec;17(6):730-8. doi: 10.1016/j.jmig.2010.06.009. Epub 2010 Sep 17.
citation: Payne TN, Dauterive FR. A comparison of total laparoscopic hysterectomy to robotically assisted hysterectomy: surgical outcomes in a community practice. J Minim Invasive Gynecol. 2008 May-Jun;15(3):286-91. doi: 10.1016/j.jmig.2008.01.008. Epub 2008 Mar 6.
citation: Sarlos D, Kots L, Stevanovic N, Schaer G. Robotic hysterectomy versus conventional laparoscopic hysterectomy: outcome and cost analyses of a matched case-control study. Eur J Obstet Gynecol Reprod Biol. 2010 May;150(1):92-6. doi: 10.1016/j.ejogrb.2010.02.012. Epub 2010 Mar 5.
citation: Shashoua AR, Gill D, Locher SR. Robotic-assisted total laparoscopic hysterectomy versus conventional total laparoscopic hysterectomy. JSLS. 2009 Jul-Sep;13(3):364-9.