Clinical trial NCT02751346: Persistent Pain After Cystectomy for Bladder Cancer
Official title: Persistent Postsurgical Pain (PPSP) Following Cystectomy: A Survey and Sensory Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Surgery
Post Operative Pain
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 383
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survey: 383 patients who have undergone cystectomy at Washington University/Barnes-Jewish Hospital.

Sensory testing: Considering 25-30% 5-year mortality rate after cystectomy for bladder cancer, we expect 10-15 subjects with PPSP and 10-15 age and gender matched controls to participate in the sensory testing portion.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Ratio of participants reporting PPSP at the time of survey.
timeFrame: between 3 months to 6 years post surgery
Secondary outcomes:
measure: 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).
timeFrame: 1 to 3 months post survey completion
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Simon Haroutounian, PhD
role: PRINCIPAL_INVESTIGATOR
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