Clinical trial NCT02435069 - References

Fecal Incontinence — A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Citation(s)

•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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.
•   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. Review.
•   Chertow GM, Brady HR
  Hyponatraemia from tap-water enema. Lancet. 1994 Sep 10;344(8924):748.
•   Chow, S
  , & Liu, J. (2014). Design and analysis of clinical trials: Concepts and methodologies (3rd ed.). Hoboken, NJ: John Wiley & Sons.
•   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.
•   Curry JI, Osborne A, Malone PS
  The MACE procedure: experience in the United Kingdom. J Pediatr Surg. 1999 Feb;34(2):338-40.
•   Dasso JF, Howell MD
  Neonatal appendectomy impairs mucosal immunity in rabbits. Cell Immunol. 1997 Nov 25;182(1):29-37.
•   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.
•   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.
•   Elder JH
  Single subject experimentation for psychiatric nursing. Arch Psychiatr Nurs. 1997 Jun;11(3):133-8. Review.
•   Forchielli ML, Walker WA
  The role of gut-associated lymphoid tissues and mucosal defence. Br J Nutr. 2005 Apr;93 Suppl 1:S41-8. Review.
•   Gast, D
  L. (2010). Single subjects research methodology in behavioral sciences. New York, NY: Routledge,Taylor & Francis Group
•   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.
•   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.
•   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.
•   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.
•   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. Review.
•   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.
•   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.
•   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.
•   Jarczyk, K
  S. (2017). A within subjects comparison of two antegrade flushing regimens in children. University of Florida, Gainesville, FL. UFE0051658
•   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. Review.
•   Jones, B
  , & Kenward, M.G. (2003). Design and analysis of cross-over trials (2nd ed.). Boca Raton, FL: Chapman & Hall/CRC.
•   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.
•   Kawanishi H
  Immunocompetence of normal human appendiceal lymphoid cells: in vitro studies. Immunology. 1987 Jan;60(1):19-28.
•   Kazdin, A
  E. (2011). Single-case research designs: Methods for clinical and applied settings (2nd ed.). New York, NY: Oxford University Press.
•   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.
•   Knox CA, Burkhart PV
  Issues related to children participating in clinical research. J Pediatr Nurs. 2007 Aug;22(4):310-8. Review.
•   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.
•   Levitt MA, Soffer SZ, Peña A
  Continent appendicostomy in the bowel management of fecally incontinent children. J Pediatr Surg. 1997 Nov;32(11):1630-3.
•   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.
•   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.
•   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.
•   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.
•   National Institutes of Health
  (1998). Policy on inclusion of children as research subjects in clinical research. Bethesda, MD: National Institutes of Health.
•   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. Review.
•   Noverr MC, Huffnagle GB
  Does the microbiota regulate immune responses outside the gut? Trends Microbiol. 2004 Dec;12(12):562-8. Review.
•   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.
•   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.
•   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. Epub 2007 Aug 17. Review.
•   Piantadosi, S
  (2005). Clinical trials: A methodologic perspective (2nd ed.). Hoboken, NJ: John Wiley & Sons.
•   Pieper P
  Ethical perspectives of children's assent for research participation: deontology and on utilitarianism. Pediatr Nurs. 2008 Jul-Aug;34(4):319-23. Review.
•   Polit, D
  F. (2010). Statistical and data analysis for nursing research (2nd ed.). New York, NY: Pearson.
•   Portney, L
  G., & Watkins, M.P. (2009). Foundations of clinical research: Applications to practice (3rd ed.). Upper Saddle River, NJ: Pearson Prentice Hall.
•   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. Epub 2007 Sep 7. Review.
•   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.
•   Rempher, K
  J., & Silkman, C. (2007). How to appraise quantitative research articles. American Nurse Today, 2, 26-28.
•   Schreiber CK, Stone AR
  Fatal hypernatremia associated with the antegrade continence enema procedure. J Urol. 1999 Oct;162(4):1433; discussion 1433-4.
•   Senn, S
  (2002). Cross-over trials in clinical research (2nd ed.). West Sussex, England: John Wiley & Sons.
•   Shuster JJ
  Student t-tests for potentially abnormal data. Stat Med. 2009 Jul 20;28(16):2170-84. doi: 10.1002/sim.3581.
•   Shuster, J
  J. (2007). Design and analysis of experiments. In W.T. Ambrosius (Ed.). Topics in biostatistics (pp. 235-259). Totowa, NJ: Humana Press.
•   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.
•   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.
•   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.
•   Stenström P, Granéli C, Salö M, Hagelsteen K, Arnbjörnsson 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.
•   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.
•   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.
•   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. Review.
•   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. Epub 2007 Oct 22.
•   Wong DL, Baker CM
  Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17.
•   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.
•   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.
•   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.

A Within Subjects Comparison of Two Antegrade Flushing Regimens in Children

Details for clinical trial NCT02435069