Last updated on February 2018

A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Brief description of study

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.

Detailed Study Description

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.

Clinical Study Identifier: NCT02435069

Find a site near you

Start Over