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
18 Years
85 Years
Female
Endometrial Cancer
Trial Information
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.
Inclusion Criteria:
- Female subjects between ages 18-86 years old
- Subject provided written consent
- Preoperative diagnosis of stage i or II endometrial cancer
- Subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at
The Ohio State University
- Subject should be expected to be able to use and tolerate opioids for pain management
- Pre operative health is graded as ASA I-III
- ECOG(Eastern Cooperative Oncology Group)Performance status 0-3
- Subject willing to comply with scheduled visits
Exclusion Criteria:
- Subject is prisoner, pregnant, or under age 18 or over age 85
- Hypersensitivity to opioids
- subject is breastfeeding
- Preoperative Health grade ASA IV-V
- ECOG Performance Status 4-5
- History of receiving prior chemotherapy or radiation therapy
- Subject schedule for additional procedures at the same time as the surgical staging
- Subject with pain related illness that to the PI discretion would interfere with
study assessments.
- Known history of alcohol, analgesic, or narcotic abuse within 12 months.
- Subjects taking NSAID(nonsteroidal anti inflammatory drug medications)within 7 days
prior to baseline visit.
- Require and/or receive chronic analgesic therapy for any pain related condition
- Severe acute or chronic medical or psychiatric condition that would interfere with
the study results.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
up to 24 hours
Safety Issue:
No
Principal Investigator
David Cohn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ohio State University
Authority:
United States: Institutional Review Board
Study ID:
OSU-08155
NCT ID:
NCT00909896
Start Date:
April 2009
Completion Date:
Related Keywords:
- Endometrial Cancer
- endometrial
- pain
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Pain, Postoperative
- Adenoma
Name | Location |
|---|---|
| The Ohio State University | Columbus, Ohio 43210 |
