A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
Condition: Fecal Incontinence; Neurogenic Bowel
MeSH terms: Fecal Incontinence; Neurogenic Bowel; Flushing
Intervention: Dose Response - NS and USP Glycerin - First Intervention; Effectiveness - NS and USP Glycerin - Second Intervention
Intervention description: 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.
Intervention MeSH terms: Pharmaceutical Solutions; Glycerol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 3 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: cecostomy; appendicostomy

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.
    

Eligibility criteria:

        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. -