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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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.
时间窗: up to 24 hours
次要结局
- 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.(up to 5 years)
研究者
David Cohn
Principal Investigator
Ohio State University Comprehensive Cancer Center