Clinical trial NCT04305730: Use of Pedometer Following Radical Cystectomy
Official title: Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Ileus
Narcotic Use
Keywords: radical cystectomy
narcotic use
post-operative ileus
return of bowel function
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
First posted: 2020-03-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a study to evaluate whether use of a pedometer following radical cystectomy decreases post-operative narcotic use and time to return of bowel function.

Detailed description: This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, return of bowel function and post-operative narcotic use. Subjects will be randomized into a control group or study group. The control group will receive standard of care, with information provided regarding the importance of ambulation following surgery. The study group will receive a pedometer with graduated step-count goals from post-operative day 0 to post-operative day 21. Both groups will be given a standardized post-operative narcotic regimen, and will be asked to record initial passage of flatus and first bowel movement. Subjects will remain on the study until post-operative day 21.

Eligibility criteria: Inclusion Criteria:

This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study.

Exclusion Criteria:

* Long-term opioid use, defined by CDC as use of opioids on most days for \>3 months
* History of inflammatory bowel disease
* Prior abdominopelvic radiation
* Travel to Europe during study period
* Concurrent surgery during radical cystectomy
* Inability to ambulate
* Gastroparesis or other baseline bowel dysmotility issues
* Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Rate of post-operative ileus
timeFrame: 7-21 days
measure: Rate of return of bowel function
timeFrame: 5-15 days
Secondary outcomes:
measure: Post-operative narcotic use
timeFrame: 7-21 days
measure: Hospital length of stay
timeFrame: 3-14 days
measure: Post-operative pain scores
timeFrame: 1-21 days
measure: Length of time under general anesthesia
timeFrame: 180-420 minutes
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: John Corman, MD
role: PRINCIPAL_INVESTIGATOR
References: