Bladder CancerNCT04305730
Use of Pedometer Following Radical Cystectomy
A study testing Use of a pedometer following surgery in people with Bladder Cancer and Ileus, run by Benaroya Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer, Ileus, Narcotic Use
- What is being tested?
- Use of a pedometer following surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2021to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
Basil A Ferenczi, MD, 206-223-6772, basil.ferenczi@virginiamason.org
About this study
Official title: Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
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.
Read the 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.
- Conditions
- Bladder Cancer, Ileus, Narcotic Use
- Being tested
- Use of a pedometer following surgery, Standard of care
- Keywords
- radical cystectomy, narcotic use, post-operative ileus, return of bowel function
- Medical subject headings
- Urinary Bladder Neoplasms, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a pedometer following surgeryBehavioural
Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
Standard of careBehavioural
Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative ileus
Standard definition
Measured: 7-21 days
Rate of return of bowel function
First passage of flatus/stool
Measured: 5-15 days
Secondary outcomes (4)
Post-operative narcotic use
Morphine equivalents used following radical cystectomy.
Measured: 7-21 days
Hospital length of stay
Time begins day of surgery to day of discharge. Time in days
Measured: 3-14 days
Post-operative pain scores
Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)
Measured: 1-21 days
Length of time under general anesthesia
Time from induction to emergence of anesthesia in minutes
Measured: 180-420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study startMar 2021 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Responsible party
- Sponsor
- Investigators
- John Corman, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305730
- Sponsor's protocol ID
- IRB 20-020
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2020
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04305730
- Acronym / sponsor ID
- IRB 20-020
- Conditions
- Bladder Cancer, Ileus, Narcotic Use
- Keywords
- radical cystectomy, narcotic use, post-operative ileus, return of bowel function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Collaborators
- Virginia Mason Hospital/Medical Center
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 12 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer Group | Experimental | Behavioral: Use of a pedometer following surgeryThis 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 |
| Control group | Active comparator | Behavioral: Standard of careThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of a pedometer following surgerySubjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description. | Behavioural | Pedometer Group |
| Standard of careSubjects in the control group will be counseled on the importance of ambulation during their pre-operative visit. | Behavioural | Control group |
Primary outcome
Rate of post-operative ileus
Time frame: 7-21 days
Standard definition
Rate of return of bowel function
Time frame: 5-15 days
First passage of flatus/stool
4 secondary outcomes
Post-operative narcotic use
Time frame: 7-21 days
Hospital length of stay
Time frame: 3-14 days
Post-operative pain scores
Time frame: 1-21 days
Length of time under general anesthesia
Time frame: 180-420 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Corman, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of a pedometer following surgery in people with Bladder Cancer and Ileus, run by Benaroya Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basil Ferenczi, MD (206-223-6600, basil.ferenczi@virginiamason.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative ileus (time frame: 7-21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.