Pelvic Pain Clinical Trial
Official title:
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.
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.
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