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Use of Pedometer Following Radical Cystectomy

Primary Purpose

Bladder Cancer, Ileus, Narcotic Use

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of a pedometer following surgery
Standard of care
Sponsored by
Benaroya Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Bladder Cancer focused on measuring radical cystectomy, narcotic use, post-operative ileus, return of bowel function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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 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.

Sites / Locations

  • Virginia Mason Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pedometer Group

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Rate of post-operative ileus
Standard definition
Rate of return of bowel function
First passage of flatus/stool

Secondary Outcome Measures

Post-operative narcotic use
Morphine equivalents used following radical cystectomy.
Hospital length of stay
Time begins day of surgery to day of discharge. Time in days
Post-operative pain scores
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Length of time under general anesthesia
Time from induction to emergence of anesthesia in minutes

Full Information

First Posted
March 4, 2020
Last Updated
February 12, 2021
Sponsor
Benaroya Research Institute
Collaborators
Virginia Mason Hospital/Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04305730
Brief Title
Use of Pedometer Following Radical Cystectomy
Official Title
Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Benaroya Research Institute
Collaborators
Virginia Mason Hospital/Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomized controlled prospective study looking at the effect of using a pedometer with graduated step-count goals following radical cystectomy on rate of ileus, 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 21. 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 post-operative day 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Ileus, Narcotic Use
Keywords
radical cystectomy, narcotic use, post-operative ileus, return of bowel function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pedometer Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Use of a pedometer following surgery
Intervention Description
Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
Primary Outcome Measure Information:
Title
Rate of post-operative ileus
Description
Standard definition
Time Frame
7-21 days
Title
Rate of return of bowel function
Description
First passage of flatus/stool
Time Frame
5-15 days
Secondary Outcome Measure Information:
Title
Post-operative narcotic use
Description
Morphine equivalents used following radical cystectomy.
Time Frame
7-21 days
Title
Hospital length of stay
Description
Time begins day of surgery to day of discharge. Time in days
Time Frame
3-14 days
Title
Post-operative pain scores
Description
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Time Frame
1-21 days
Title
Length of time under general anesthesia
Description
Time from induction to emergence of anesthesia in minutes
Time Frame
180-420 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Basil Ferenczi, MD
Phone
206-223-6600
Email
basil.ferenczi@virginiamason.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Corman, MD
Organizational Affiliation
Virginia Mason Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basil A Ferenczi, MD
Phone
206-223-6772
Email
basil.ferenczi@virginiamason.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Use of Pedometer Following Radical Cystectomy

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