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Spots Global Cancer Trial Database for Persistent Pain After Cystectomy for Bladder Cancer

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Trial Identification

Brief Title: Persistent Pain After Cystectomy for Bladder Cancer

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

Study ID: NCT02751346

Interventions

Study Description

Brief Summary: 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Washington University in St. Louis, Saint Louis, Missouri, United States

Contact Details

Name: Simon Haroutounian, PhD

Affiliation: Washington University School of Medicine

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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