Study of Conventional Laparoscopic Hysterectomy Versus Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution
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|ClinicalTrials.gov Identifier: NCT01581905|
Recruitment Status : Terminated (Trial was redesigned as a new trial)
First Posted : April 20, 2012
Last Update Posted : January 20, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia Dysfunctional Uterine Bleeding Leiomyoma Pelvic Pain Endometriosis||Procedure: Conventional Laparoscopic Hysterectomy (LH) Procedure: Robot Assisted Hysterectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Comparing Conventional Laparoscopic Hysterectomy With Robot-Assisted Laparoscopic Hysterectomy at a Teaching Institution|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||June 2013|
Active Comparator: LH Group
The LH Group includes individuals undergoing conventional laparoscopic hysterectomy, total or supracervical.
Procedure: Conventional Laparoscopic Hysterectomy (LH)
Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
Other Name: LH Group
Active Comparator: RH Group
The RH Group includes individuals undergoing Robot-Assisted laparoscopic hysterectomy, total or supracervical.
Procedure: Robot Assisted Hysterectomy
Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
Other Name: RH Group
- 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 [ Time Frame: Intraoperative complications will be measured on the day of surgery after completing the procedure. ]Intraoperative complications include: injury to bladder, ureters, bowel, blood vessels,and nerves AND hemorrhage
- Perioperative Complications [ Time Frame: Perioperative complications will be measured on the date of discharge from the hospital. ]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)
- Early Postoperative Complications [ 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. ]Early postoperative complications include: pulmonary, renal, and cerebrovascular morbidity, wound and vault complications (infection, breakdown, and dehiscence); septicemia, and thromboembolic complications (DVT, PE)
- Delayed Post-Operative Complications [ Time Frame: Delayed post-operative complications will be measured from 2 weeks until 8 weeks after surgery, up to 56 days post-operatively. ]Delayed post-operative complications include: incisional hernia formation, re-operation, vaginal evisceration
- Costs [ Time Frame: Cost will be assessed 8 weeks after completion of the surgery, up to 56 days post-operatively. ]Costs will include the costs of pre-operative care, surgery, post-operative care, and any post-operative complications.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01581905
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Janis L Green, MD||Milton S. Hershey Medical Center|
|Study Director:||Gerald J Harkins, MD||Milton S. Hershey Medical Center|
|Study Chair:||Matthew Davies, MD||Milton S. Hershey Medical Center|