Use of Pedometer Following Radical Prostatectomy

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Laparoscopic Robot Assisted Radical Prostatectomy

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

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer; Ambulation Difficulty
• 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 prostatectomy on 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 14. 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 initial post-operative visit.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• 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
      • Recruiting
      • Virginia Mason Medical Center
      • Contact: Basil 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: Male

Description

Inclusion Criteria:

This study will include men 18-75 undergoing robot-assisted laparoscopic radical prostatectomy for prostate cancer at Virginia Mason Medical Center.

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 prostatectomy
• 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 prostatectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 2,000/day. POD 3-6: 3,000/day. POD 7-9: 4,000/day. POD 10-14: 5,000/day.	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 prostatectomy, 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
Post operative narcotic use	Morphine equivalents used following radical prostatectomy.	7-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of return of bowel function	First passage of flatus and first bowel movement following surgery	7-14 days

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 (Actual): February 10, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: radical prostatectomy; pedometer; return of bowel function; post-operative narcotic use
• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: IRB19-096

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