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Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Intensive Preoperative Ostomy Education for the Radical Cystectomy Patient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03462667
Acronym
StomABC
Enrollment
65
Registered
2018-03-12
Start date
2018-02-26
Completion date
2020-03-01
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Ileostomy

Brief summary

The purpose of this study is to learn if the stoma boot camp is a good and effective way to help people adapt to life with a stoma after surgery.

Detailed description

Bladder cancer is the fifth most common cancer in the USA. The primary treatment for invasive bladder cancer is a radical cystectomy (RC) with a urinary diversion. Patients that have this procedure must deal with a stoma that requires daily care and manual skills. A stoma is an artificial opening that allows urine to pass from the ureters outside the body. Having a surgery that results in a stoma can dramatically change a person's life. This study is being done to test a new education session called the stoma boot camp. The session was created to help people deal with changes in their post-surgery life and living with a stoma. The session requires a one time visit to the study site and lasts about two hours. Participants can bring a support person to the boot camp if they choose. During the two hour session, nurses will provide teaching, counseling, and hands on practice with an artificial stoma.

Interventions

BEHAVIORALStoma Boot Camp

Educational session designed to prepare people for living life with a stoma.

OTHERStandard of Care

Patients receive normal pre-surgery standard of care.

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must be presumed to undergo a radical cystectomy with ileal conduit diversion * Diagnosis of bladder cancer

Exclusion criteria

* Patients undergoing a radical cystectomy with ileal conduit for any reason other than bladder cancer will not be allowed to participate

Design outcomes

Primary

MeasureTime frameDescription
Ostomy adjustment scaleChange from Baseline to 30 Days After Date of SurgeryThe Ostomy Adjustment Scale evaluates a person with an ostomy following surgery. The instrument consists of 34 statements. Scores range from a minimum of 34 to a maximum of 204. The higher the score, the better the person's perceived adjustment.

Secondary

MeasureTime frameDescription
Length of hospital stayDate of Admission to Date of Discharge, up to 7 daysMeasured as the date of admission to discharge.
Count of un-planned stoma-related interventions in community after discharge30 Days After Date of SurgeryUnplanned stoma-related interventions will include any admission to any hospital after being discharged, from the time the patient goes home up until 30 days after the date of the surgery, along with any stoma related visit outside of the normal follow-up pathway to a clinic or any stoma related phone calls received by urology or ostomy staff.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026