Study of Post Operative Pain in Endometrial Cancer Robotic Versus Laparotomy
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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 |
|---|
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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 |
- 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 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 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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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 |
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.
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| United States, Ohio | |
| The Ohio State University | |
| Columbus,, Ohio, United States, 43210 | |
| 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: | March 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
endometrial pain |
Additional relevant MeSH terms:
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Endometrial Neoplasms Sarcoma, Endometrial Stromal Pain, Postoperative Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female |
Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Postoperative Complications Pathologic Processes Pain Signs and Symptoms Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 23, 2013