Prospective, Double Arm, Comparative Study for the Evaluation of Postoperative Pain, QOL, and Determination of Inflammatory Markers In Patients Undergoing Robotics Versus Open Laparotomy Approach for Staging of Endometrial Cancer
The primary objective is to measure and compare postoperative pain at rest at several time
points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients
undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
Post operative Quality of Life will also be collected at several time points. The total
amount of post operative opioid requirements during the first 24hours between patients
undergoing either robotic or open laparotomy approach surgery. The survival status every
four months for the first two years will be monitored, then every 6 months for up to 5
years. The primary endpoint is the mean difference in post operative pain VAS scores
reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours
between both groups after surgery has been completed.
Observational Model: Cohort, Time Perspective: Prospective
The outcome measure is mean difference in post operative pain VAS scores reported by subjects at rest at the several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.
up to 24 hours
David Cohn, MD
Ohio State University
United States: Institutional Review Board
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