Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic 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|
|Study Completion Date:||April 2015|
|Primary Completion Date:||October 2014 (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|