Use of Pedometer Following Radical Cystectomy

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy

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.

Study Overview

• Status: Unknown
• Conditions: Bladder Cancer; Ileus; Narcotic Use
• Intervention / Treatment: Behavioral: Use of a pedometer following surgery; Behavioral: Standard of care

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Basil Ferenczi, MD; Phone Number: 206-223-6600; Email: basil.ferenczi@virginiamason.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center
      • Contact: Basil A Ferenczi, MD; Phone Number: 206-223-6772; Email: basil.ferenczi@virginiamason.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pedometer Group; 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	Behavioral: Use of a pedometer following surgery; Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
Active Comparator: Control group; 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.	Behavioral: Standard of care; Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of post-operative ileus	Standard definition	7-21 days
Rate of return of bowel function	First passage of flatus/stool	5-15 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Benaroya Research Institute
• Collaborators: Virginia Mason Hospital/Medical Center
• Investigators: Principal Investigator: John Corman, MD, Virginia Mason Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 12, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: radical cystectomy; return of bowel function; post-operative ileus; narcotic use
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Urinary Bladder Neoplasms; Ileus
• Other Study ID Numbers: IRB 20-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No