A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 3 - 12 |
| Updated: | 12/14/2017 |
| Start Date: | November 2015 |
| End Date: | May 2018 |
| Contact: | Kimberly S Jarczyk, MSN |
| Email: | kjarczyk@nemours.org |
| Phone: | 1-800-767-5437 |
There is a surgical procedure to help children with intractable fecal incontinence gain
continence for stool through construction of a tube that connects the abdominal wall to the
colon near or through the appendix. This tube allows easy administration of enema solution
into the first part of the colon. Putting enema solution through that tube into the colon is
called an antegrade continence enema or ACE and has been shown to work well in helping some
but not all children prevent stool accidents. The purpose of this study is to compare a large
volume ACE flush using a salt water solution called normal saline with a small volume ACE
flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose
and flush frequency of each solution; 2) compare which solution given at the best dose takes
the least amount of time to clear the colon of stool, has the least side effects, and is the
most effective in preventing stool accidents; and 3) to determine if administration of either
of the ACE flushing solution affects colon health and the bacteria in the colon.
continence for stool through construction of a tube that connects the abdominal wall to the
colon near or through the appendix. This tube allows easy administration of enema solution
into the first part of the colon. Putting enema solution through that tube into the colon is
called an antegrade continence enema or ACE and has been shown to work well in helping some
but not all children prevent stool accidents. The purpose of this study is to compare a large
volume ACE flush using a salt water solution called normal saline with a small volume ACE
flush using liquid glycerin. The aims of this study are to: 1) find the most effective dose
and flush frequency of each solution; 2) compare which solution given at the best dose takes
the least amount of time to clear the colon of stool, has the least side effects, and is the
most effective in preventing stool accidents; and 3) to determine if administration of either
of the ACE flushing solution affects colon health and the bacteria in the colon.
Fecal incontinence past the time of toilet training is devastating to affected children.
Antegrade continence enema (ACE) therapy administered through a catheterizable stoma
surgically placed in the cecum has helped children with intractable fecal incontinence attain
continence for stool. There are a number of retrospective studies demonstrating the variable
effectiveness rates of ACE therapy. This variability may be due to what is used to flush.
There are no prospective trials evaluating the effectiveness of different flushing regimens.
. The catheterizable stoma used for the antegrade administration of enema solution is
frequently made by bringing the appendix out through the abdominal wall or by placing a
skin-level device (button) in to the cecum. ACE therapy administration through the appendix
or into the cecum has the potential to disrupt the gut microbial ecosystem, causing dysbiosis
and immune dysfunction. The effects of ACE administration on colonic microbiome and mucosal
immunity have not been investigated. This pilot study will compare a high volume normal
saline (NS) flush and a low volume USP glycerin flush. The primary aims of the study are to
compare which solution, given at an optimal dose and frequency, is delivered in the least
amount of time, with fewer side effects, while promoting the higher degree of fecal
continence and quality of life, and to determine if administration of antegrade enema
solution through an appendicostomy/cecostomy affects gut microbiota.
Antegrade continence enema (ACE) therapy administered through a catheterizable stoma
surgically placed in the cecum has helped children with intractable fecal incontinence attain
continence for stool. There are a number of retrospective studies demonstrating the variable
effectiveness rates of ACE therapy. This variability may be due to what is used to flush.
There are no prospective trials evaluating the effectiveness of different flushing regimens.
. The catheterizable stoma used for the antegrade administration of enema solution is
frequently made by bringing the appendix out through the abdominal wall or by placing a
skin-level device (button) in to the cecum. ACE therapy administration through the appendix
or into the cecum has the potential to disrupt the gut microbial ecosystem, causing dysbiosis
and immune dysfunction. The effects of ACE administration on colonic microbiome and mucosal
immunity have not been investigated. This pilot study will compare a high volume normal
saline (NS) flush and a low volume USP glycerin flush. The primary aims of the study are to
compare which solution, given at an optimal dose and frequency, is delivered in the least
amount of time, with fewer side effects, while promoting the higher degree of fecal
continence and quality of life, and to determine if administration of antegrade enema
solution through an appendicostomy/cecostomy affects gut microbiota.
Inclusion Criteria:
- This study will involve twelve children ages 3 to 12 years recruited from subspecialty
clinics at Nemours Children's Subspecialty Care and the Pediatric Spinal Defects
Clinic in Jacksonville, Florida.
- Children will be selected by purposive sampling and will include those who are
scheduled to have an ACE stoma and will require regular antegrade enema administration
to maintain continence.
Exclusion Criteria:
- Excluded will be children with preexisting electrolyte imbalance, chronic high rectal
tone, quadriplegia, renal or cardiac disease, or those who require prophylactic
antibiotics, cannot communicate, or have significant cognitive delay that would
interfere with their ability to fully participate in the study.
- Parents must have English language competency and be willing and able to participate
in administration or oversight of the flushing regimen and data collection for a
minimum of 20 consecutive weeks. -
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