Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy|
- Operative Time [ Time Frame: Intra operative ] [ Designated as safety issue: No ]The primary end point is difference in operative time
- Complications [ Time Frame: up to 6 weeks following intervention ] [ Designated as safety issue: Yes ]Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Laparoscopic Hysterectomy
The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.
The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02118974
|United States, Pennsylvania|
|Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|