Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female subjects ages 18-85 years old, Pre operative diagnosis of clinical stage I or II endometrial cancer, Subject able to tolerate use of opioids for pain management, Eastern Cooperative Oncology Group (ECOG)0-3.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Robotic Surgery candidates; Group of patients receive Robotic approach for endometrial cancer staging
Open Laparotomy Surgical Candidates; Patients receiving open laparotomy for endometrial cancer surgical staging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: David Cohn, MD, Ohio State University

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2009
• Primary Completion (Actual): January 29, 2013
• Study Completion (Actual): January 29, 2013

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): May 29, 2009

Study Record Updates

• Last Update Posted (Actual): April 2, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: pain; endometrial
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: OSU-08155