Brief Title
Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy
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
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 Type
Observational
Primary Outcome
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.
Secondary Outcome
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.
Condition
Endometrial Cancer
Study Arms / Comparison Groups
Robotic Surgery candidates
Description: Group of patients receive Robotic approach for endometrial cancer staging
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
142
Start Date
April 8, 2009
Completion Date
January 29, 2013
Primary Completion Date
January 29, 2013
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.
Gender
Female
Ages
18 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
David Cohn, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00909896
Organization ID
OSU-08155
Responsible Party
Principal Investigator
Study Sponsor
Ohio State University Comprehensive Cancer Center
Study Sponsor
David Cohn, MD, Principal Investigator, Ohio State University
Verification Date
March 2018