Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

Completed

Conditions studied: Endometrial Cancer

In brief

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 postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

Key facts

Study ID

NCT00909896

Run by

Ohio State University Comprehensive Cancer Center

People needed

142

Starts

2009-04-08

Expected to finish

2013-01-29

Last updated by the study team

2018-04-02

Who can join

Age: 18 and older, up to 85. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Ohio State University — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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