Factors Affecting Perioperative Outcomes
Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse
The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.
- Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
- Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.
A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.
研究概览
地位
条件
详细说明
Objectives: The purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population.
Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.
研究类型
联系人和位置
学习地点
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Oklahoma
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Oklahoma City、Oklahoma、美国、73104
- University of Oklahoma Health Sciences Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Age at least 21
- Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center
Exclusion Criteria:
- Age < 21
- Inability to complete the written questionnaires
- Undergoing concurrent procedures for condition other than pelvic organ prolapse
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
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Abdominal
- Participants undergoing surgeries with an abdominal approach will be given a Morphine PCA at a dose of 2mg every 10 minutes with a 12mg/hour lockout.
They will also be given IV Toradol at 30mg every 6 hours as needed for a maximum of four doses.
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Vaginal
- Participants undergoing surgeries with a vaginal approach will be given hydrocodone/acetaminophen at a dose of 5/325 (1-2 tablets every four hours as needed), and provided with Ibuprofen 800mg every 8 hours as needed.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Perioperative complications
大体时间:1 week
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1 week
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Analgesic use
大体时间:1 week
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1 week
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Length of hospital stay
大体时间:1 week
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1 week
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合作者和调查者
调查人员
- 首席研究员:Mikio Nihira, MD、University of Oklahoma
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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