跳至主要内容
临床试验/NCT01530191
NCT01530191撤回不适用

Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse

University of Oklahoma1 个研究点 分布在 1 个国家开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Perioperative complications

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age at least 21
  • Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center

排除标准

  • Age < 21
  • Inability to complete the written questionnaires
  • Undergoing concurrent procedures for condition other than pelvic organ prolapse

结局指标

主要结局

Perioperative complications

时间窗: 1 week

Analgesic use

时间窗: 1 week

Length of hospital stay

时间窗: 1 week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验