Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

Completed

• Conditions: Endometrial Cancer

• Registration Number: NCT00909896
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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 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.

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 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.

Study Timeline

• Study Start: 2009-04-08
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Primary Completion: 2013-01-29
• Study Completion: 2013-01-29
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes will include the measurement of post operative pain after leg extension, post operative quality of life, post operative opioid requirements during first 24hours, survival status up to five years.	up to 5 years

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States