Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

NCT ID: NCT00909896

Last Updated: 2018-04-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 142 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-08
• Study Completion Date: 2013-01-29

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.

Conditions

Endometrial Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Robotic Surgery candidates

Group of patients receive Robotic approach for endometrial cancer staging

No interventions assigned to this group

Open Laparotomy Surgical Candidates

Patients receiving open laparotomy for endometrial cancer surgical staging

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

David Cohn

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Cohn, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

OSU-08155

Identifier Type: -

Identifier Source: org_study_id