Use of Pedometer Following Radical Prostatectomy

NCT ID: NCT04206280

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2021-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Prostate Cancer Ambulation Difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Use of a pedometer following surgery

Intervention Type BEHAVIORAL

Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Standard of care

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role collaborator

Benaroya Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Corman, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

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Virginia Mason Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Basil Ferenczi, MD

Role: CONTACT

206-223-6600

Facility Contacts

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Basil Ferenczi, MD

Role: primary

206-223-6772

Other Identifiers

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IRB19-096

Identifier Type: -

Identifier Source: org_study_id

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