Persistent Pain After Cystectomy for Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT02751346|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : October 4, 2018
|Condition or disease|
|Pain Surgery Post Operative Pain|
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.
|Study Type :||Observational|
|Actual Enrollment :||383 participants|
|Official Title:||Persistent Postsurgical Pain (PPSP) Following Cystectomy: A Survey and Sensory Examination|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||February 2017|
Patients with Pain
Patients with pain identified through the survey will be invited to undergo sensory assessment by quantitative sensory testing (QST) around the surgical scar and a control area: Thermal (cold and heat) detection and pain thresholds; mechanical detection and pain threshold; dynamic mechanical allodynia; temporal summation (wind-up).
Patients without Pain
Patients without pain age and gender matched to patients with pain identified through the survey will be invited to undergo sensory assessment by quantitative sensory testing (QST) around the surgical scar and a control area: Thermal (cold and heat) detection and pain thresholds; mechanical detection and pain threshold; dynamic mechanical allodynia; temporal summation (wind-up).
- Ratio of participants reporting PPSP at the time of survey. [ Time Frame: 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.
- 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). [ Time Frame: 1 to 3 months post survey completion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751346
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Simon Haroutounian, PhD||Washington University School of Medicine|