Clinical trial NCT02435069: A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
Official title: A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fecal Incontinence
Neurogenic Bowel
Keywords: cecostomy
appendicostomy
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: University of Florida
First posted: 2015-05-06
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 (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.

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. -

Primary outcomes:
measure: Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen
timeFrame: Data collection started following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.
measure: Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin
timeFrame: Data collection began following consent and procedural training and was collected daily from day 1 for the duration of the study, an average of 135 days.
Secondary outcomes:
measure: NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence
timeFrame: Frequency of administration data was collected as the total number of flushes recieved over the last three days of each dosing phase for both NS and USP Glycerin and recorded as either daily (1), every other day (2), or every third day
measure: Flush Volume
timeFrame: Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study
measure: Number of Participants With Any Electrolyte Abnormality
timeFrame: Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples
measure: 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
timeFrame: Collection dates included a baseline sample (week 1) and at the completion of the dosing trail for both NS and USP glycerin for a total of 3 samples
measure: Cramping With Flush
timeFrame: Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase
measure: Number of Participants Experiencing Vagal Symptoms With Flush
timeFrame: Data collection started with the first flush administered following discharge from the hospital and was collected with every subsequent flush through completion of the study, an average of 115 days.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Specialty Care
name: Kimberly S Jarczyk, PhD
role: PRINCIPAL_INVESTIGATOR
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