Clinical Trial: A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Brief Summary: 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.