NCT04305730

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

March 4, 2020

Last Update Submit

February 12, 2021

Conditions

Bladder CancerIleusNarcotic Use

Keywords

radical cystectomynarcotic usepost-operative ileusreturn of bowel function

Outcome Measures

Primary Outcomes (2)

  • Rate of post-operative ileus

    Standard definition

    7-21 days

  • Rate of return of bowel function

    First passage of flatus/stool

    5-15 days

Secondary Outcomes (4)

  • Post-operative narcotic use

    7-21 days

  • Hospital length of stay

    3-14 days

  • Post-operative pain scores

    1-21 days

  • Length of time under general anesthesia

    180-420 minutes

Study Arms (2)

Pedometer Group

EXPERIMENTAL

This group will be given a pedometer following radical cystectomy. Subjects in the experimental group will have a graduated step-count goal as follows: POD 0-2: 1,000/day. POD 3-6: 2,000/day. POD 7-9: 3,000/day. POD 10-14: 4,000/day. POD 14-21: 5,000

Behavioral: Use of a pedometer following surgery

Control group

ACTIVE COMPARATOR

This is the control group. Following radical cystectomy subjects in the control group will receive standard of care, which includes counseling regarding the importance of ambulation following surgery.

Behavioral: Standard of care

Interventions

Use of a pedometer following surgeryBEHAVIORAL

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

Pedometer Group
Standard of careBEHAVIORAL

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

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • This study will include men and women age18-75 undergoing radical cystectomy for bladder cancer at Virginia Mason Medical Center. This includes both open and robot-assisted radical cystectomy, and all types of urinary diversion will be included in the trial. Subjects both with and without neo-adjuvant chemotherapy will be included in the study.

You may not qualify if:

  • 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 cystectomy
  • Inability to ambulate
  • Gastroparesis or other baseline bowel dysmotility issues
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Urinary Bladder NeoplasmsIleus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • John Corman, MD

    Virginia Mason Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Basil Ferenczi, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 12, 2020

Study Start

March 1, 2021

Primary Completion

March 1, 2021

Study Completion

May 1, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)