Use of Pedometer Following Radical Prostatectomy

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206280
• Other study ID #: IRB19-096
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: February 2021

Study information

• Verified date: December 2019
• Source: Benaroya Research Institute
• Contact: Basil Ferenczi, MD
• Phone: 206-223-6600
• Email: basil.ferenczi[@]virginiamason.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ambulation Difficulty
• Mobility Limitation
• Prostate Cancer

Intervention

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.
• Standard of care
Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative narcotic use	Morphine equivalents used following radical prostatectomy.	7-14 days
Secondary	Rate of return of bowel function	First passage of flatus and first bowel movement following surgery	7-14 days