Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05253196 |
| Other study ID # |
21-2976 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
May 2023 |
| Source |
University of Colorado, Denver |
| Contact |
Jill Ketzer |
| Phone |
720-777-4960 |
| Email |
Jill.Ketzer[@]childrenscolorado.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The International Center for Colorectal and Urogenital Care at Children's Hospital Colorado
treats patients who suffer from many different colorectal issues such as anorectal
malformation, Hirschsprung disease, and severe constipation. Many of these patients suffer
from fecal incontinence. The investigators have developed a week long bowel management
program (BMP) that is offered every month to help these kids stay clean of stool in the
underwear, by finding the perfect enema recipe to clean the colon for 24 hours. This allows
one to perform an enema once every day, clean their colon, and remain free of 'accidents'.
Many spina bifida patients also suffer from fecal incontinence and are referred to this BMP.
The overall success rate for all patients who suffer from fecal incontinence is 95%, however
the success rate for spina bifida patients is only 77%. The reason for this decrease in
success is due to the lack of anal sphincter tone in spina bifida patients, which leads to
inadvertent leakage and spillage of enema fluid and bowel content during enema
administration. The purpose of this study is to create and test an enema administration
device that improves upon current methods.
Description:
Patients meeting inclusion criteria will be enrolled while they are here on campus for a
regular clinic visit. Once they consent, they will complete a baseline survey, and will be
given the FCAD with the instruction manual and the investigators will go over how to use the
device and answer any questions. The PI will be available throughout the study for any
questions that may arise. Participants will use the device for their regular enemas for up to
4 weeks. If the device is negatively impacting enema administration, they can choose to stop
using the device at any time but it is preferable that participants use the device five times
before they decide it is not working for them. Once a participant has used the device for 4
weeks or has chosen to opt out of completing the 4-week trial, they will complete a second
survey. The baseline survey will assess how current enema administration practices are going
and the second survey will assess how well enema administration is going while using the
device. If time allows and user feedback indicates a need, the device will be modified, and
participants asked to use the second version for up to 4 weeks. Again, if the device is
negatively impacting enema administration, they can choose to stop using the second version
of the device at any time but it's preferable that participants use it five times before
deciding it is not working for them. Once a participant has used the second version of the
device for 4 weeks, or chosen to opt out of completing the 4-week trial, they will complete a
third survey assessing the second version of the device. If traveling to CHCO is not
convenient, the second version of the device will be mailed to the participant and they will
complete the surveys via email or over the phone. This eliminates the need for a return trip
to CHCO. REDCap will be used for all surveys. If participants are not able to complete the
surveys electronically for any reason, they will complete a hardcopy version, or the survey
will be administered over the phone, whichever is convenient for the participant.
