Use of Pedometer Following Radical Cystectomy

Not Applicable

• Conditions: Bladder Cancer; Ileus; Narcotic Use

• Registration Number: NCT04305730
• Lead Sponsor: Benaroya Research Institute

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.

Study Timeline

• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-12
• Last Update Posted: 2021-02-16
• Study Start: 2021-03
• Primary Completion: 2021-03
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of return of bowel function	5-15 days	First passage of flatus/stool
Rate of post-operative ileus	7-21 days	Standard definition

Secondary Outcome Measures

Name	Time	Method
Post-operative narcotic use	7-21 days	Morphine equivalents used following radical cystectomy.
Post-operative pain scores	1-21 days	Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Hospital length of stay	3-14 days	Time begins day of surgery to day of discharge. Time in days
Length of time under general anesthesia	180-420 minutes	Time from induction to emergence of anesthesia in minutes

Trial Locations

Locations (1)

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States