Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy
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|ClinicalTrials.gov Identifier: NCT02118974|
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : January 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia Pelvic Pain Hysterectomy||Procedure: Hysterectomy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||April 2015|
Experimental: Laparoscopic Hysterectomy
- Operative Time [ Time Frame: Intra operative ]The primary end point is difference in operative time
- Complications [ Time Frame: up to 6 weeks following intervention ]Complications related to the procedure including delays in discharge and re-admissions will be monitored and evaluated individually throughout the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118974
|United States, Pennsylvania|
|Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|