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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
  Purpose

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.


Condition
Endometrial Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: April 2009
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909896

Locations
United States, Ohio
The Ohio State University
Columbus,, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: David Cohn, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: David Cohn, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00909896     History of Changes
Other Study ID Numbers: OSU-08155
Study First Received: May 28, 2009
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
endometrial
pain

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014