Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909896
• Other study ID #: OSU-08155
• Status: Completed
• First received: May 28, 2009
• Last updated: March 30, 2018
• Start date: April 8, 2009
• Est. completion date: January 29, 2013

Study information

• Verified date: March 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: January 29, 2013
• Est. primary completion date: January 29, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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