Use of Pedometer Following Radical Cystectomy

Bladder Cancer Clinical Trial

Official title:

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Cystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04305730
• Other study ID #: IRB 20-020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: May 2021

Study information

• Verified date: February 2021
• Source: Benaroya Research Institute
• Contact: Basil Ferenczi, MD
• Phone: 206-223-6600
• Email: basil.ferenczi[@]virginiamason.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 35
• Est. completion date: May 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Ileus
• Narcotic Use
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of post-operative ileus	Standard definition	7-21 days
Primary	Rate of return of bowel function	First passage of flatus/stool	5-15 days
Secondary	Post-operative narcotic use	Morphine equivalents used following radical cystectomy.	7-21 days
Secondary	Hospital length of stay	Time begins day of surgery to day of discharge. Time in days	3-14 days
Secondary	Post-operative pain scores	Numerical Rating Scale Pain Scores (Range: 0-10, where 0 is no pain and 10 is the worst pain)	1-21 days
Secondary	Length of time under general anesthesia	Time from induction to emergence of anesthesia in minutes	180-420 minutes