Children, Only Clinical Trial
Official title:
Randomized Controlled Trial Comparing Split-versus Standard-dose Sodium Pico Sulfate Plus Magnesium Citrate for Bowel Cleansing Before Colonoscopy in Children
Before having a colonoscopy, it is necessary to clean the intestine well in order to have a complete view of the intestinal mucosa. Preparations consisting of osmotic agents are used to clean the intestines, which are sometimes difficult to drink. In this study we want to evaluate whether the preparation, based on sodium picosulfate plus magnesium citrate (PMC), is easier for the patient to take all day before the exam or half the day before and half the same morning of procedure and which method of intake allows the doctor to better conduct the examination. The primary objective of this study will be to compare the efficacy, tolerability and acceptability of two dosage regimens of sodium picosulfate plus magnesium citrate (PMC). Effectiveness means which of the two methods of taking the preparation works best for cleaning the intestine, with tolerability if one of the two methods is easier for the patient and with acceptability if one of the two methods is easier than the other.
Status | Not yet recruiting |
Enrollment | 590 |
Est. completion date | July 16, 2022 |
Est. primary completion date | April 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: • children aged 2-18 years undergoing elective colonoscopy Exclusion Criteria: - requirement for urgent colonoscopy - bowel obstruction, - known or suspected hypersensitivity to the active or other ingredients - clinically significant electrolyte imbalance - prior intestinal resection - known metabolic, renal and cardiac disease. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Azienda Ospedaliera "Sant'Andrea" |
ASGE Standards of Practice Committee, Lightdale JR, Acosta R, Shergill AK, Chandrasekhara V, Chathadi K, Early D, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Kashab M, Muthusamy VR, Pasha S, Saltzman JR, Cash BD; American Society for Gastrointestinal Endoscopy. Modifications in endoscopic practice for pediatric patients. Gastrointest Endosc. 2014 May;79(5):699-710. doi: 10.1016/j.gie.2013.08.014. Epub 2014 Mar 1. — View Citation
Barkun A, Chiba N, Enns R, Marcon M, Natsheh S, Pham C, Sadowski D, Vanner S. Commonly used preparations for colonoscopy: efficacy, tolerability, and safety--a Canadian Association of Gastroenterology position paper. Can J Gastroenterol. 2006 Nov;20(11):699-710. Review. — View Citation
Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007 Feb 15;25(4):373-84. Review. — View Citation
Dahshan A, Lin CH, Peters J, Thomas R, Tolia V. A randomized, prospective study to evaluate the efficacy and acceptance of three bowel preparations for colonoscopy in children. Am J Gastroenterol. 1999 Dec;94(12):3497-501. — View Citation
Di Nardo G, Aloi M, Cucchiara S, Spada C, Hassan C, Civitelli F, Nuti F, Ziparo C, Pession A, Lima M, La Torre G, Oliva S. Bowel preparations for colonoscopy: an RCT. Pediatrics. 2014 Aug;134(2):249-56. doi: 10.1542/peds.2014-0131. Epub 2014 Jul 7. — View Citation
Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP. Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc. 2005 Mar;61(3):378-84. — View Citation
Hassan C, East J, Radaelli F, Spada C, Benamouzig R, Bisschops R, Bretthauer M, Dekker E, Dinis-Ribeiro M, Ferlitsch M, Fuccio L, Awadie H, Gralnek I, Jover R, Kaminski MF, Pellisé M, Triantafyllou K, Vanella G, Mangas-Sanjuan C, Frazzoni L, Van Hooft JE, Dumonceau JM. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2019. Endoscopy. 2019 Aug;51(8):775-794. doi: 10.1055/a-0959-0505. Epub 2019 Jul 11. — View Citation
Hunter A, Mamula P. Bowel preparation for pediatric colonoscopy procedures. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):254-61. doi: 10.1097/MPG.0b013e3181eb6a1c. Review. — View Citation
Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):620-5. doi: 10.1016/j.gie.2008.05.057. Epub 2009 Jan 10. — View Citation
Manes G, Repici A, Hassan C; MAGIC-P study group. Randomized controlled trial comparing efficacy and acceptability of split- and standard-dose sodium picosulfate plus magnesium citrate for bowel cleansing prior to colonoscopy. Endoscopy. 2014 Aug;46(8):662-9. doi: 10.1055/s-0034-1365800. Epub 2014 Jul 14. — View Citation
Martel M, Barkun AN, Menard C, Restellini S, Kherad O, Vanasse A. Split-Dose Preparations Are Superior to Day-Before Bowel Cleansing Regimens: A Meta-analysis. Gastroenterology. 2015 Jul;149(1):79-88. doi: 10.1053/j.gastro.2015.04.004. Epub 2015 Apr 8. — View Citation
Pall H, Zacur GM, Kramer RE, Lirio RA, Manfredi M, Shah M, Stephen TC, Tucker N, Gibbons TE, Sahn B, McOmber M, Friedlander J, Quiros JA, Fishman DS, Mamula P. Bowel preparation for pediatric colonoscopy: report of the NASPGHAN endoscopy and procedures committee. J Pediatr Gastroenterol Nutr. 2014 Sep;59(3):409-16. doi: 10.1097/MPG.0000000000000447. Review. — View Citation
Sriphongphankul H, Tanpowpong P, Lertudomphonwanit C, Treepongkaruna S. Split dose versus full single-dose regimen of polyethylene glycol for bowel preparation in pediatric colonoscopy: a pilot study of randomized controlled trial. Eur J Gastroenterol Hepatol. 2019 Nov;31(11):1382-1386. doi: 10.1097/MEG.0000000000001562. — View Citation
Tripathi PR, Poddar U, Yachha SK, Sarma MS, Srivastava A. Efficacy of Single- Versus Split-dose Polyethylene Glycol for Colonic Preparation in Children: A Randomized Control Study. J Pediatr Gastroenterol Nutr. 2020 Jan;70(1):e1-e6. doi: 10.1097/MPG.0000000000002511. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best Colonic Cleansing in 590 pediatric patient underwent colonoscopy | Primary outcome will be the overall colon cleansing defined as the rate of successful cleansing (excellent and good scores in the BBPS, i.e. = 6 points) of the two preparation regimen. | 18 months | |
Secondary | the rate of adverse events | Percentage of adverse events between two preparation regimen | 18 months | |
Secondary | the rate of specific symptoms associated to colonic lavage solutions | percentage of symptoms associated to bowel preparation | 18 months | |
Secondary | the rate of children who declared that they would be willing to repeat the same preparation regimen if needed | percentage of children well tollerate the praparation taken | 18 months | |
Secondary | the rate of children who declared that the intake of the solution was easy | percentage of children not discomfort to drink solution | 18 months | |
Secondary | the rate of children taking an amount of solution = 75% | Percentage of patient take sufficient dose of bowel preparation | 18 months |
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