Phase 4 Completed N=5 Randomized Supportive Care

A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Source: ClinicalTrials.gov NCT02435069 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcomePrimary: Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen — 1; 4 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen	1; 4	—
PRIMARY Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin	2; 0.2	0.069751
SECONDARY NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence	1; 1.6	0.172
SECONDARY Flush Volume	39.215; 1.475	—
SECONDARY Number of Participants With Any Electrolyte Abnormality	0; 0	—
SECONDARY Change in Stool Calprotectin Levels Assessed Through Comparing Levels Obtained Following Completion of NS and USP Glycerin Dosing Phases With the Baseline Value For Each Subject	133.7; 108	0.8028
SECONDARY Cramping With Flush	0; 0.4	0.346594
SECONDARY Number of Participants Experiencing Vagal Symptoms With Flush	0; 1	—

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. -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02435069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.