A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
Condition: Fecal Incontinence; Neurogenic Bowel
MeSH terms: Fecal Incontinence; Neurogenic Bowel; Flushing
Study type: Interventional
Phase: Phase 4

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 (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 needed to prevent stool accidents; 2) compare which
      solution given at the best dose has the least side effects and 3) to determine if
      administration of either of the ACE flushing solutions causes electrolyte abnormalities or
      affects colon health.
    

Detailed 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 cause colonic dysfunction. The effects of ACE
      administration on colonic mucosal health has not been investigated. This pilot study will
      compare a high volume normal saline (NS) flush and a low volume United States Pharmacopeia
      (USP) glycerin flush. The primary aims of the study are to compare which solution, given at
      an optimal dose and frequency, is associated with fewer side effects, while promoting the
      higher degree of fecal continence, and to determine if antegrade enema solution
      administration through an appendicostomy/cecostomy causes electrolyte abnormalities or
      affects gut health.
    

Intervention name(s): Dose Response - NS and USP Glycerin - First Intervention; Effectiveness - NS and USP Glycerin - Second Intervention
Intervention type(s): Drug; Drug
Intervention description(s): This trial used a repeated measures, single subjects alternating treatments A-B-C-B'-C'-B1' withdrawal design in which all subjects were tested under all conditions and each subject acted as his or her own control. The subjects were randomly assigned to either normal saline or USP glycerin to control for order effects. Baseline data A served as the control and was obtained pre-operatively. The B-C arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration of NS and USP Glycerin necessary to promote fecal continence. When the optimal dose as identified, the child continued on that dose for 2 weeks to insure treatment stability and effectiveness.; To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they have achieved continence with minimal side effects on optimal dosing The second phase B'-C'-B1' of the study compared the two regimens at optimal dose and administration frequency. This phase was used to confirm the effectiveness of NS and USP Glycerin at optimal dosing on continence and assess side effects.
Other intervention name(s): 0.9% sodium chloride solution, Glycerol, Glycerin; 0.9% sodium chloride solution, Glycerol, Glycerin
Intervention MeSH terms: Pharmaceutical Solutions; Glycerol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: cecostomy; appendicostomy