Use of Pedometer Following Radical Cystectomy

Benaroya Research Institute

Status: Unknown

Conditions: Ileus; Bladder Cancer; Narcotic Use

Treatments: Behavioral: Standard of care; Behavioral: Use of a pedometer following surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04305730

IRB 20-020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Pedometer Group

Experimental group

Description:

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

Treatment:

Behavioral: Use of a pedometer following surgery

Control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard of care