Recruiting

Observational Study

Sponsor:

Benaroya Research Institute

Code:

NCT04206280

Conditions

Prostate Cancer

Ambulation Difficulty

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Use of a pedometer following surgery

Standard of care

Study Details

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.

Conditions

Prostate Cancer

Ambulation Difficulty

Study ID

NCT04206280

Start date

Feb 10, 2020

Status verified date

Dec, 2019

Completion date

Feb, 2021

Anticipated

Primary completion date

Dec, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Post operative narcotic use [ Time Frame: 7-14 days ]

Central Contacts and Locations

Central contacts

Basil Ferenczi, MD

206-223-6600basil.ferenczi@virginiamason.org

Locations

Virginia Mason Medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Basil Ferenczi, MD

206-223-6772basil.ferenczi@virginiamason.org

More Information

Sponsor

Benaroya Research Institute

Last update posted

Feb 11, 2020

Last verified

Dec, 2019

Keywords

  • radical prostatectomy
  • pedometer
  • return of bowel function
  • post-operative narcotic use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2020-02-11.