Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Cohn, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00909896
First received: May 28, 2009
Last updated: December 9, 2013
Last verified: December 2013

May 28, 2009
December 9, 2013
April 2009
December 2014   (final data collection date for primary outcome measure)
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. [ Time Frame: up to 24 hours ] [ Designated as safety issue: No ]
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. [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00909896 on ClinicalTrials.gov Archive Site
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. [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
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. [ Time Frame: 5 eyars ] [ Designated as safety issue: No ]
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

Endometrial Cancer
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Female
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00909896
OSU-08155
No
David Cohn, Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center
Not Provided
Principal Investigator: David Cohn, MD Ohio State University
Ohio State University Comprehensive Cancer Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP