Use of Pedometer Following Radical Cystectomy

Not Applicable

• Conditions: Bladder Cancer; Ileus; Narcotic Use
• Interventions: Behavioral: Use of a pedometer following surgery; Behavioral: Standard of care

• 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

Arm && Interventions

Group	Intervention	Description
Pedometer Group	Use of a pedometer following surgery	This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000
Control group	Standard of care	This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.

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