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临床试验/NCT02751346
NCT02751346已完成不适用

Persistent Postsurgical Pain (PPSP) Following Cystectomy: A Survey and Sensory Examination

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
383
试验地点
1
主要终点
Ratio of participants reporting PPSP at the time of survey.

研究概览

简要总结

This single-center, cross-sectional survey and sensory examination is conducted to determine the prevalence, sensory characteristics and risk factors of PPSP in patients who underwent cystectomy at Washington University/Barnes-Jewish Hospital between 2009 and 2015. Based on data from other lower abdominal surgeries, the investigators hypothesize that 10-15% of patients undergoing cystectomy will develop PPSP.

详细描述

Currently, open radical cystectomy (ORC) with urinary diversion is the standard treatment for patient with muscle-invasive organ-confined bladder cancer. ORC involves the complete resection of local metastatic disease and reconstruction of a functional urinary tract. Additionally, minimally invasive laparoscopic surgery was shown to be safe alternative to open radical cystectomy. A total of 29,719 patients underwent a form of cystectomy in the United States between 2009 and 2011. Both cystectomy procedures require a midline incision on the pubic symphysis, and as with virtually any surgical incision, it produces tissue injury and inflammation, which result is acute post-operative pain.

Acute pain after surgery typically subsides with tissue healing; however, some patients go on to develop persistent post-surgical pain (PPSP). It is estimated that 21-52% of people who had underwent thoracotomy, 21.5-47.3% of women who had breast surgery, and 4.7%-18% of people who had underwent abdominal surgery developed PPSP. The incidence of the condition varies substantially by the type of surgical procedure, which is also an important factor affecting the mechanism of PPSP. For example, while thoracic surgeries result in predominantly neuropathic pain due to intraoperative nerve injury, in hysterectomies and knee replacement surgeries the mechanisms of PPSP seem to be predominantly inflammatory. However, no data are currently available on the prevalence or potential mechanisms of PPSP after cystectomy.

Understanding the prevalence, risk factors, and the potential mechanisms underlying PPSP after cystectomy will serve the basis for investigating approaches for risk stratification and prevention of PPSP in bladder cancer patients undergoing the procedure.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Age greater than or equal to 18;
  • Cystectomy for bladder cancer performed at Washington University/Barnes-Jewish Hospital between Jan 1, 2009 and June 30, 2015.

排除标准

  • Surveys will not be sent if any of the following criteria exist:
  • Patient is deceased or has moved out of the United States.
  • Preoperative record indicates multiple surgeries in the abdominopelvic region.

结局指标

主要结局

Ratio of participants reporting PPSP at the time of survey.

时间窗: between 3 months to 6 years post surgery

Presence of PPSP will be determined based on presence of pain in the pelvic area at the time of survey.

次要结局

  • Comparison of sensory findings between patients with PPSP and patients without PPSP after cystectomy. This specific aim will be attained by performing Quantitative Sensory Testing (QST).(1 to 3 months post survey completion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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