Use of Pedometer Following Radical Prostatectomy

Sponsor

Benaroya Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT04206280

Collaborator

Virginia Mason Hospital/Medical Center (Other)

Enrollment

Location

Arms

11.7

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Ambulation Difficulty	Behavioral: Use of a pedometer following surgery Behavioral: Standard of care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 10, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Post operative narcotic use [7-14 days]
Morphine equivalents used following radical prostatectomy.

Secondary Outcome Measures

Rate of return of bowel function [7-14 days]
First passage of flatus and first bowel movement following surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Mason Medical Center	Seattle	Washington	United States	98101

Sponsors and Collaborators

Benaroya Research Institute
Virginia Mason Hospital/Medical Center

Investigators

Principal Investigator: John Corman, MD, Virginia Mason Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benaroya Research Institute

ClinicalTrials.gov Identifier:

NCT04206280

Other Study ID Numbers:

IRB19-096

First Posted:

Dec 20, 2019

Last Update Posted:

Feb 11, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Benaroya Research Institute

radical prostatectomy

pedometer

return of bowel function

post-operative narcotic use

Additional relevant MeSH terms:

Mobility Limitation

Study Results

No Results Posted as of Feb 11, 2020