Persistent Pain After Cystectomy for Bladder Cancer

October 3, 2018 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
between 3 months to 6 years post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 to 3 months post survey completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Simon Haroutounian, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201509131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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