Status:
COMPLETED
Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-85 years
Brief Summary
This study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. The primary objective is to measure and compare...
Detailed Description
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 ro...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 8 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 29 2013
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00909896
Start Date
April 8 2009
End Date
January 29 2013
Last Update
April 2 2018
Active Locations (1)
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1
The Ohio State University
Columbus, Ohio, United States, 43210