search
Back to results

A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Primary Purpose

Fecal Incontinence, Neurogenic Bowel

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dose Response - NS and USP Glycerin - First Intervention
Effectiveness - NS and USP Glycerin - Second Intervention
Sponsored by
Nemours Children's Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fecal Incontinence focused on measuring cecostomy, appendicostomy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Nemours Children's Specialty Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Pre-operative Baseline Phase

Dose Response - NS and USP Glycerin - First Intervention

NS and USP Glycerin - Effectiveness - Second Intervention

Arm Description

Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control.

Initial flush used NS or USP Glycerin randomized to treatment sequence. The starting volume and administration frequency for NS was 10mL/kg and glycerin 20 mL administered every other day. The NS dose was titrated in 10 mL increments to achieve continence so as not to exceed 500 mL daily for a child under five years of age and 1000 mL daily for a child over 5 years of age. USP Glycerin was titrated in 5 mL increments so as not to exceed 50 mL daily. For side effects greater than Wong Bailey Faces Pain Rating Scale (WBFPRS) level 4, NS was decreased by 2.5 mL/kg to the lowest dose of 5 mL/kg daily. USP Glycerin was decreased in 5 mL increments to the lowest dose of 5 mL daily. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was be trialed on the alternate therapy and then dropped from the study.

To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they achieved continence on optimal dosing with minimal side effects.This arm evaluated the long term effectiveness of NS and glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence.

Outcomes

Primary Outcome Measures

Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush.
Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%).

Secondary Outcome Measures

NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence
Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.
Flush Volume
Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen.
Number of Participants With Any Electrolyte Abnormality
Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin.
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
Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order.
Cramping With Flush
Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase.
Number of Participants Experiencing Vagal Symptoms With Flush
Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin.

Full Information

First Posted
April 27, 2015
Last Updated
August 23, 2019
Sponsor
Nemours Children's Clinic
Collaborators
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT02435069
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2016 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence, Neurogenic Bowel
Keywords
cecostomy, appendicostomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-operative Baseline Phase
Arm Type
No Intervention
Arm Description
Baseline data including frequency and severity of fecal soiling and frequency and severity of abdominal pain were collected for a minimum of 2 weeks prior to surgical construction of the ACE stoma. Baseline stool calprotectin and serum electrolytes were collected in the baseline phase prior to initiation of the preoperative bowel prep. Pre-operative data served as the control.
Arm Title
Dose Response - NS and USP Glycerin - First Intervention
Arm Type
Experimental
Arm Description
Initial flush used NS or USP Glycerin randomized to treatment sequence. The starting volume and administration frequency for NS was 10mL/kg and glycerin 20 mL administered every other day. The NS dose was titrated in 10 mL increments to achieve continence so as not to exceed 500 mL daily for a child under five years of age and 1000 mL daily for a child over 5 years of age. USP Glycerin was titrated in 5 mL increments so as not to exceed 50 mL daily. For side effects greater than Wong Bailey Faces Pain Rating Scale (WBFPRS) level 4, NS was decreased by 2.5 mL/kg to the lowest dose of 5 mL/kg daily. USP Glycerin was decreased in 5 mL increments to the lowest dose of 5 mL daily. If the maximum dose did not result in continence, if the dose necessary to minimize side effects resulted in fecal soiling, or if there were side effects greater than WBFPRS level 4 at the lowest dose of administration, the child was be trialed on the alternate therapy and then dropped from the study.
Arm Title
NS and USP Glycerin - Effectiveness - Second Intervention
Arm Type
Experimental
Arm Description
To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they achieved continence on optimal dosing with minimal side effects.This arm evaluated the long term effectiveness of NS and glycerin at optimal dose and administration frequency for 4 weeks and served as comparison between flush solutions. The study concluded with the child being placed back on 2 weeks of the initial flush in the randomized sequence.
Intervention Type
Drug
Intervention Name(s)
Dose Response - NS and USP Glycerin - First Intervention
Other Intervention Name(s)
0.9% sodium chloride solution, Glycerol, Glycerin
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.
Intervention Type
Drug
Intervention Name(s)
Effectiveness - NS and USP Glycerin - Second Intervention
Other Intervention Name(s)
0.9% sodium chloride solution, Glycerol, Glycerin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fecal Soiling - Number of Participants That Gained and Maintained Continence on Each Flushing Regimen
Description
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. The purpose of this outcome measure was to document the number of individuals who gained continence on NS and USP glycerin. Descriptive statistics was limited to percentage of total participants who achieved continence on each flushing regimen. Data was calculated on the last data point in the final phase for both the NS and USP glycerin flush.
Time Frame
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.
Title
Fecal Soiling - Quantitative Count Detailing the Number of Episodes of Fecal Incontinence Per Day on NS and USP Glycerin
Description
Fecal soiling was defined as non-toilet elimination, which was tracked and documented by the parent/child as direct event recording and tallied as the number of pairs of underwear/protective undergarments soiled with stool per day. Descriptive statistics included mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05, calculated on the data from the last day of the completed NS and USP Glycerin phases of the study. Power analysis conducted using data from this study with α = 0.5, power of .80, correlation between two means of .598, and effect size of 1.554 estimated a sample size of 11 would be needed to minimize the risk of a Type II error to (20%).
Time Frame
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 Outcome Measure Information:
Title
NS and USP Glycerin Flush Solution Dosing Frequency Necessary to Achieve Continence
Description
Flush administration frequency necessary to achieve continence was recorded as a single measure per subject per flush solution obtained as the number of flushes in the last three days of each dosing phase and recorded as either daily (1), every other day (2), or every third day (3). The larger the value, the less frequent the flush, the better the clinical outcome. Dosing frequency was measured using direct observational recording completed by the parent or child. Descriptive analysis included mean, and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the data from the last day of the completed NS and USP Glycerin phases of the study.
Time Frame
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
Title
Flush Volume
Description
Flush volume was measured in mL/flush using a graduated cylinder and recorded by the parent or child with each flush and later calculated in mL/kg. Data derived from the last flush of the completed dosing phase of both NS and USP Glycerin were used to calculate flush volume. Descriptive analysis included mean, median, range, and standard deviation. Reported data excludes subjects who failed to gain and maintain continence on either flushing regimen.
Time Frame
Data for analysis was collected from the last flush of the NS and USP Glycerin dosing phase of the study
Title
Number of Participants With Any Electrolyte Abnormality
Description
Evaluated impact of NS and USP Glycerin antegrade flush on serum electrolytes using a blood test called a Basic Metabolic Panel. Data analysis limited to percentage of subjects demonstrating any electrolyte abnormality on NS or USP glycerin.
Time Frame
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
Title
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
Description
Stool calprotectin was used to evaluate the impact of NS and USP Glycerin antegrade flush on colonic health. Calprotectin levels were obtained at baseline and following completion of the NS and USP Glycerin dosing phase of the study. Descriptive data analysis included mean and standard deviation for each flush regimen. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Both descriptive and inferential data analysis was calculated on the difference in calprotectin levels between samples obtained at baseline and samples obtained following the completion of the NS and USP Glycerin flush (value at completion of dosing phase - baseline value). The assumption was the length of each dosing phase was sufficient to achieve a credible active washout period and therefore levels obtained at the end of a phase reflected flushing regimen effects colonic health regardless of flush order.
Time Frame
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
Title
Cramping With Flush
Description
Cramping with flush was measured using the Wong Baker Faces Pain Rating Scale (WBFPRS). The WBFPRS has undergone extensive testing and has well established psychometrics in the pediatric population. The scale ranges from 0 (very happy without pain) to 10 (the worse pain imaginable). Each pain level is associated with a facial expression. The child is asked to choose the face that best describes his/her level of discomfort (ordinal data). The parent was instructed to call if the child had flushing regimen-associated discomfort greater than a 4 on the WBFPRS. Documentation of pain severity was completed by the parent and child on a data-collection form at the time of occurrence. Descriptive statistics including mean and standard deviation. Inferential statistical analysis was accomplished using a two-tailed, two-sample pooled variance t test with a significance level set at 0.05. Descriptive and inferential statistics were calculated on the last data point in the dosing phase.
Time Frame
Data analysis was completed on data obtained during the last flush in both the NS and USP Glycerin dosing phase
Title
Number of Participants Experiencing Vagal Symptoms With Flush
Description
Vagal symptoms including nausea, vomiting, sweating, dizziness, and pallor were noted by the parent. The parent was instructed to call if the child had any vagal symptoms. Documentation of any vagal symptoms was completed by the parent and child on a data-collection form at the time of occurrence. Data was analyzed as a percentage of subjects experiencing vagal symptoms during flush with NS and USP glycerin.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly S Jarczyk, PhD
Organizational Affiliation
Nemours Children's Specialty Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Specialty Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11875145
Citation
Aksnes G, Diseth TH, Helseth A, Edwin B, Stange M, Aafos G, Emblem R. Appendicostomy for antegrade enema: effects on somatic and psychosocial functioning in children with myelomeningocele. Pediatrics. 2002 Mar;109(3):484-9. doi: 10.1542/peds.109.3.484.
Results Reference
background
PubMed Identifier
12512028
Citation
Andersson RE, Olaison G, Tysk C, Ekbom A. Appendectomy is followed by increased risk of Crohn's disease. Gastroenterology. 2003 Jan;124(1):40-6. doi: 10.1053/gast.2003.50021.
Results Reference
background
PubMed Identifier
19635308
Citation
Aspirot A, Fernandez S, Di Lorenzo C, Skaggs B, Mousa H. Antegrade enemas for defecation disorders: do they improve the colonic motility? J Pediatr Surg. 2009 Aug;44(8):1575-80. doi: 10.1016/j.jpedsurg.2008.11.061.
Results Reference
background
PubMed Identifier
18721951
Citation
Bani-Hani AH, Cain MP, King S, Rink RC. Tap water irrigation and additives to optimize success with the Malone antegrade continence enema: the Indiana University algorithm. J Urol. 2008 Oct;180(4 Suppl):1757-60; discussion 1760. doi: 10.1016/j.juro.2008.04.074. Epub 2008 Aug 21.
Results Reference
background
PubMed Identifier
22674333
Citation
Balter M. Taking stock of the human microbiome and disease. Science. 2012 Jun 8;336(6086):1246-7. doi: 10.1126/science.336.6086.1246. Epub 2012 Jun 6. No abstract available.
Results Reference
background
PubMed Identifier
15325028
Citation
Bazar KA, Lee PY, Joon Yun A. An "eye" in the gut: the appendix as a sentinel sensory organ of the immune intelligence network. Med Hypotheses. 2004;63(4):752-8. doi: 10.1016/j.mehy.2004.04.008.
Results Reference
background
PubMed Identifier
18926220
Citation
Becmeur F, Demarche M, Lacreuse I, Molinaro F, Kauffmann I, Moog R, Donnars F, Rebeuh J. Cecostomy button for antegrade enemas: survey of 29 patients. J Pediatr Surg. 2008 Oct;43(10):1853-7. doi: 10.1016/j.jpedsurg.2008.03.043.
Results Reference
background
PubMed Identifier
11507793
Citation
Biglan A, Ary D, Wagenaar AC. The value of interrupted time-series experiments for community intervention research. Prev Sci. 2000 Mar;1(1):31-49. doi: 10.1023/a:1010024016308.
Results Reference
background
PubMed Identifier
7915790
Citation
Chertow GM, Brady HR. Hyponatraemia from tap-water enema. Lancet. 1994 Sep 10;344(8924):748. doi: 10.1016/s0140-6736(94)92236-5. No abstract available.
Results Reference
background
Citation
Chow, S., & Liu, J. (2014). Design and analysis of clinical trials: Concepts and methodologies (3rd ed.). Hoboken, NJ: John Wiley & Sons.
Results Reference
background
PubMed Identifier
22986031
Citation
Chu DI, Balsara ZR, Routh JC, Ross SS, Wiener JS. Experience with glycerin for antegrade continence enema in patients with neurogenic bowel. J Urol. 2013 Feb;189(2):690-3. doi: 10.1016/j.juro.2012.08.209. Epub 2012 Oct 8.
Results Reference
background
PubMed Identifier
10052818
Citation
Curry JI, Osborne A, Malone PS. The MACE procedure: experience in the United Kingdom. J Pediatr Surg. 1999 Feb;34(2):338-40. doi: 10.1016/s0022-3468(99)90204-x.
Results Reference
background
PubMed Identifier
9427807
Citation
Dasso JF, Howell MD. Neonatal appendectomy impairs mucosal immunity in rabbits. Cell Immunol. 1997 Nov 25;182(1):29-37. doi: 10.1006/cimm.1997.1216.
Results Reference
background
PubMed Identifier
12592621
Citation
Dey R, Ferguson C, Kenny SE, Shankar KR, Coldicutt P, Baillie CT, Lamont GL, Lloyd DA, Losty PD, Turnock RR. After the honeymoon--medium-term outcome of antegrade continence enema procedure. J Pediatr Surg. 2003 Jan;38(1):65-8; discussion 65-8. doi: 10.1053/jpsu.2003.50012.
Results Reference
background
PubMed Identifier
27817835
Citation
Dolejs SC, Smith JK Jr, Sheplock J, Croffie JM, Rescorla FJ. Contemporary short- and long-term outcomes in patients with unremitting constipation and fecal incontinence treated with an antegrade continence enema. J Pediatr Surg. 2017 Jan;52(1):79-83. doi: 10.1016/j.jpedsurg.2016.10.022. Epub 2016 Oct 27.
Results Reference
background
PubMed Identifier
9193118
Citation
Elder JH. Single subject experimentation for psychiatric nursing. Arch Psychiatr Nurs. 1997 Jun;11(3):133-8. doi: 10.1016/s0883-9417(97)80036-2.
Results Reference
background
PubMed Identifier
15877894
Citation
Forchielli ML, Walker WA. The role of gut-associated lymphoid tissues and mucosal defence. Br J Nutr. 2005 Apr;93 Suppl 1:S41-8. doi: 10.1079/bjn20041356.
Results Reference
background
Citation
Gast, D.L. (2010). Single subjects research methodology in behavioral sciences. New York, NY: Routledge,Taylor & Francis Group
Results Reference
background
PubMed Identifier
15681775
Citation
Gebbers JO, Laissue JA. Bacterial translocation in the normal human appendix parallels the development of the local immune system. Ann N Y Acad Sci. 2004 Dec;1029:337-43. doi: 10.1196/annals.1309.015.
Results Reference
background
PubMed Identifier
20890219
Citation
Gomez R, Mousa H, Liem O, Hayes J, Di Lorenzo C. How do antegrade enemas work? Colonic motility in response to administration of normal saline solution into the proximal colon. J Pediatr Gastroenterol Nutr. 2010 Dec;51(6):741-6. doi: 10.1097/MPG.0b013e3181e75d18.
Results Reference
background
PubMed Identifier
16795632
Citation
Hartmann DP, Gottman JM, Jones RR, Gardner W, Kazdin AE, Vaught RS. Interrupted time-series analysis and its application to behavioral data. J Appl Behav Anal. 1980 Winter;13(4):543-59. doi: 10.1901/jaba.1980.13-543.
Results Reference
background
PubMed Identifier
9269980
Citation
Helikson MA, Parham WA, Tobias JD. Hypocalcemia and hyperphosphatemia after phosphate enema use in a child. J Pediatr Surg. 1997 Aug;32(8):1244-6. doi: 10.1016/s0022-3468(97)90692-8.
Results Reference
background
PubMed Identifier
22674334
Citation
Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6.
Results Reference
background
PubMed Identifier
10697146
Citation
Ismail EA, Al-Mutairi G, Al-Anzy H. A fatal small dose of phosphate enema in a young child with no renal or gastrointestinal abnormality. J Pediatr Gastroenterol Nutr. 2000 Feb;30(2):220-1. doi: 10.1097/00005176-200002000-00025. No abstract available.
Results Reference
background
Citation
Janosky, J.E., Leininger, S.L., Hoerger, M.P., & Libkuman, T.M. (2009). Single subjects designs in biomedicine. New York, NY: Springer Science + Business Media.
Results Reference
background
PubMed Identifier
21632600
Citation
Janszky I, Mukamal KJ, Dalman C, Hammar N, Ahnve S. Childhood appendectomy, tonsillectomy, and risk for premature acute myocardial infarction--a nationwide population-based cohort study. Eur Heart J. 2011 Sep;32(18):2290-6. doi: 10.1093/eurheartj/ehr137. Epub 2011 Jun 1.
Results Reference
background
PubMed Identifier
18239669
Citation
Jia W, Li H, Zhao L, Nicholson JK. Gut microbiota: a potential new territory for drug targeting. Nat Rev Drug Discov. 2008 Feb;7(2):123-9. doi: 10.1038/nrd2505.
Results Reference
background
Citation
Jones, B., & Kenward, M.G. (2003). Design and analysis of cross-over trials (2nd ed.). Boca Raton, FL: Chapman & Hall/CRC.
Results Reference
background
PubMed Identifier
20706148
Citation
Kaugars AS, Silverman A, Kinservik M, Heinze S, Reinemann L, Sander M, Schneider B, Sood M. Families' perspectives on the effect of constipation and fecal incontinence on quality of life. J Pediatr Gastroenterol Nutr. 2010 Dec;51(6):747-52. doi: 10.1097/MPG.0b013e3181de0651.
Results Reference
background
PubMed Identifier
3493205
Citation
Kawanishi H. Immunocompetence of normal human appendiceal lymphoid cells: in vitro studies. Immunology. 1987 Jan;60(1):19-28.
Results Reference
background
Citation
Kazdin, A.E. (2011). Single-case research designs: Methods for clinical and applied settings (2nd ed.). New York, NY: Oxford University Press.
Results Reference
background
PubMed Identifier
16338323
Citation
King SK, Sutcliffe JR, Southwell BR, Chait PG, Hutson JM. The antegrade continence enema successfully treats idiopathic slow-transit constipation. J Pediatr Surg. 2005 Dec;40(12):1935-40. doi: 10.1016/j.jpedsurg.2005.08.011.
Results Reference
background
PubMed Identifier
17645958
Citation
Knox CA, Burkhart PV. Issues related to children participating in clinical research. J Pediatr Nurs. 2007 Aug;22(4):310-8. doi: 10.1016/j.pedn.2007.02.004.
Results Reference
background
PubMed Identifier
27614699
Citation
Large T, Szymanski KM, Whittam B, Misseri R, Chan KH, Kaefer M, Rink RC, Cain MP. Ambulatory patients with spina bifida are 50% more likely to be fecally continent than non-ambulatory patients, particularly after a MACE procedure. J Pediatr Urol. 2017 Feb;13(1):60.e1-60.e6. doi: 10.1016/j.jpurol.2016.06.019. Epub 2016 Aug 24.
Results Reference
background
PubMed Identifier
9396543
Citation
Levitt MA, Soffer SZ, Pena A. Continent appendicostomy in the bowel management of fecally incontinent children. J Pediatr Surg. 1997 Nov;32(11):1630-3. doi: 10.1016/s0022-3468(97)90470-x.
Results Reference
background
PubMed Identifier
16894232
Citation
Ma HH. An alternative method for quantitative synthesis of single-subject researches: percentage of data points exceeding the median. Behav Modif. 2006 Sep;30(5):598-617. doi: 10.1177/0145445504272974.
Results Reference
background
PubMed Identifier
11479862
Citation
Marshall J, Hutson JM, Anticich N, Stanton MP. Antegrade continence enemas in the treatment of slow-transit constipation. J Pediatr Surg. 2001 Aug;36(8):1227-30. doi: 10.1053/jpsu.2001.25768.
Results Reference
background
PubMed Identifier
20198477
Citation
Matsuno D, Yamazaki Y, Shiroyanagi Y, Ueda N, Suzuki M, Nishi M, Hagiwara A, Ichiroku T. The role of the retrograde colonic enema in children with spina bifida: is it inferior to the antegrade continence enema? Pediatr Surg Int. 2010 May;26(5):529-33. doi: 10.1007/s00383-010-2585-6. Epub 2010 Mar 3.
Results Reference
background
PubMed Identifier
18721959
Citation
Nanigian DK, Nguyen T, Tanaka ST, Cambio A, DiGrande A, Kurzrock EA. Development and validation of the fecal incontinence and constipation quality of life measure in children with spina bifida. J Urol. 2008 Oct;180(4 Suppl):1770-3; discussion 1773. doi: 10.1016/j.juro.2008.03.103. Epub 2008 Aug 21.
Results Reference
background
PubMed Identifier
22674330
Citation
Nicholson JK, Holmes E, Kinross J, Burcelin R, Gibson G, Jia W, Pettersson S. Host-gut microbiota metabolic interactions. Science. 2012 Jun 8;336(6086):1262-7. doi: 10.1126/science.1223813. Epub 2012 Jun 6.
Results Reference
background
Citation
National Institutes of Health. (1998). Policy on inclusion of children as research subjects in clinical research. Bethesda, MD: National Institutes of Health.
Results Reference
background
PubMed Identifier
15539116
Citation
Noverr MC, Huffnagle GB. Does the microbiota regulate immune responses outside the gut? Trends Microbiol. 2004 Dec;12(12):562-8. doi: 10.1016/j.tim.2004.10.008.
Results Reference
background
PubMed Identifier
21527223
Citation
Ok JH, Kurzrock EA. Objective measurement of quality of life changes after ACE Malone using the FICQOL survey. J Pediatr Urol. 2011 Jun;7(3):389-93. doi: 10.1016/j.jpurol.2011.02.012. Epub 2011 Apr 27.
Results Reference
background
PubMed Identifier
24443094
Citation
Peeraully MR, Lopes J, Wright A, Davies BW, Stewart RJ, Singh SS, More BB. Experience of the MACE procedure at a regional pediatric surgical unit: a 15-year retrospective review. Eur J Pediatr Surg. 2014 Feb;24(1):113-6. doi: 10.1055/s-0033-1357502. Epub 2014 Jan 17.
Results Reference
background
PubMed Identifier
17711557
Citation
Penders J, Stobberingh EE, van den Brandt PA, Thijs C. The role of the intestinal microbiota in the development of atopic disorders. Allergy. 2007 Nov;62(11):1223-36. doi: 10.1111/j.1398-9995.2007.01462.x. Epub 2007 Aug 17.
Results Reference
background
Citation
Piantadosi, S. (2005). Clinical trials: A methodologic perspective (2nd ed.). Hoboken, NJ: John Wiley & Sons.
Results Reference
background
PubMed Identifier
18814566
Citation
Pieper P. Ethical perspectives of children's assent for research participation: deontology and on utilitarianism. Pediatr Nurs. 2008 Jul-Aug;34(4):319-23.
Results Reference
background
Citation
Polit, D.F. (2010). Statistical and data analysis for nursing research (2nd ed.). New York, NY: Pearson.
Results Reference
background
Citation
Portney, L.G., & Watkins, M.P. (2009). Foundations of clinical research: Applications to practice (3rd ed.). Upper Saddle River, NJ: Pearson Prentice Hall.
Results Reference
background
PubMed Identifier
17936308
Citation
Randal Bollinger R, Barbas AS, Bush EL, Lin SS, Parker W. Biofilms in the large bowel suggest an apparent function of the human vermiform appendix. J Theor Biol. 2007 Dec 21;249(4):826-31. doi: 10.1016/j.jtbi.2007.08.032. Epub 2007 Sep 7.
Results Reference
background
PubMed Identifier
25148747
Citation
Randall J, Coyne P, Jaffray B. Follow up of children undergoing antegrade continent enema: experience of over two hundred cases. J Pediatr Surg. 2014 Sep;49(9):1405-8. doi: 10.1016/j.jpedsurg.2014.02.090.
Results Reference
background
Citation
Rempher, K.J., & Silkman, C. (2007). How to appraise quantitative research articles. American Nurse Today, 2, 26-28.
Results Reference
background
PubMed Identifier
10492231
Citation
Schreiber CK, Stone AR. Fatal hypernatremia associated with the antegrade continence enema procedure. J Urol. 1999 Oct;162(4):1433; discussion 1433-4. doi: 10.1016/s0022-5347(05)68331-0. No abstract available.
Results Reference
background
Citation
Senn, S. (2002). Cross-over trials in clinical research (2nd ed.). West Sussex, England: John Wiley & Sons.
Results Reference
background
PubMed Identifier
18450053
Citation
Shuster JJ. Design and analysis of experiments. Methods Mol Biol. 2007;404:235-59. doi: 10.1007/978-1-59745-530-5_12.
Results Reference
background
PubMed Identifier
19326398
Citation
Shuster JJ. Student t-tests for potentially abnormal data. Stat Med. 2009 Jul 20;28(16):2170-84. doi: 10.1002/sim.3581.
Results Reference
background
PubMed Identifier
21502828
Citation
Siddiqui AA, Fishman SJ, Bauer SB, Nurko S. Long-term follow-up of patients after antegrade continence enema procedure. J Pediatr Gastroenterol Nutr. 2011 May;52(5):574-80. doi: 10.1097/MPG.0b013e3181ff6042.
Results Reference
background
PubMed Identifier
18408942
Citation
Sinha CK, Grewal A, Ward HC. Antegrade continence enema (ACE): current practice. Pediatr Surg Int. 2008 Jun;24(6):685-8. doi: 10.1007/s00383-008-2130-z. Epub 2008 Apr 12.
Results Reference
background
PubMed Identifier
19678866
Citation
Smith HF, Fisher RE, Everett ML, Thomas AD, Bollinger RR, Parker W. Comparative anatomy and phylogenetic distribution of the mammalian cecal appendix. J Evol Biol. 2009 Oct;22(10):1984-99. doi: 10.1111/j.1420-9101.2009.01809.x. Epub 2009 Aug 12.
Results Reference
background
PubMed Identifier
24175287
Citation
Stenstrom P, Graneli C, Salo M, Hagelsteen K, Arnbjornsson E. Appendicostomy in preschool children with anorectal malformation: successful early bowel management with a high frequency of minor complications. Biomed Res Int. 2013;2013:297084. doi: 10.1155/2013/297084. Epub 2013 Sep 23.
Results Reference
background
PubMed Identifier
16945657
Citation
Thomas JC, Dietrich MS, Trusler L, DeMarco RT, Pope JC 4th, Brock JW 3rd, Adams MC. Continent catheterizable channels and the timing of their complications. J Urol. 2006 Oct;176(4 Pt 2):1816-20; discussion 1820. doi: 10.1016/S0022-5347(06)00610-0.
Results Reference
background
PubMed Identifier
20954103
Citation
Tiryaki S, Ergun O, Celik A, Ulman I, Avanoglu A. Success of Malone's antegrade continence enema (MACE) from the patients' perspective. Eur J Pediatr Surg. 2010 Nov;20(6):405-7. doi: 10.1055/s-0030-1265156. Epub 2010 Oct 15.
Results Reference
background
PubMed Identifier
20921070
Citation
Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
Results Reference
background
PubMed Identifier
17945290
Citation
Vande Velde S, Van Biervliet S, Van Renterghem K, Van Laecke E, Hoebeke P, Van Winckel M. Achieving fecal continence in patients with spina bifida: a descriptive cohort study. J Urol. 2007 Dec;178(6):2640-4; discussion 2644. doi: 10.1016/j.juro.2007.07.060. Epub 2007 Oct 22.
Results Reference
background
PubMed Identifier
3344163
Citation
Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
Results Reference
background
PubMed Identifier
19524753
Citation
Yardley IE, Pauniaho SL, Baillie CT, Turnock RR, Coldicutt P, Lamont GL, Kenny SE. After the honeymoon comes divorce: long-term use of the antegrade continence enema procedure. J Pediatr Surg. 2009 Jun;44(6):1274-6; discussion 1276-7. doi: 10.1016/j.jpedsurg.2009.02.030.
Results Reference
background
PubMed Identifier
11547116
Citation
Yerkes EB, Rink RC, King S, Cain MP, Kaefer M, Casale AJ. Tap water and the Malone antegrade continence enema: a safe combination? J Urol. 2001 Oct;166(4):1476-8.
Results Reference
background
PubMed Identifier
11930097
Citation
Youssef NN, Barksdale Jr E, Griffiths JM, Flores AF, Di Lorenzo C. Management of intractable constipation with antegrade enemas in neurologically intact children. J Pediatr Gastroenterol Nutr. 2002 Apr;34(4):402-5. doi: 10.1097/00005176-200204000-00016.
Results Reference
background
Citation
Jarczyk, K.S. (2017). A within subjects comparison of two antegrade flushing regimens in children. University of Florida, Gainesville, FL. UFE0051658
Results Reference
result

Learn more about this trial

A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

We'll reach out to this number within 24 hrs