Efficacy and Safety of Split-dose Citrafleet Administered From 2 to 6 Hours Before Morning Colonoscopies
NCT ID: NCT01481714
Last Updated: 2011-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
300 participants
INTERVENTIONAL
2011-11-30
2012-06-30
Brief Summary
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The aim of the study is to evaluate the efficacy and safety of a sodium-picosulphate low-volume split-dose regimen, in which the second-half of the preparation and fluids intake are allowed until 2 hours for early morning colonoscopies and until 2-6 hours for morning colonoscopies, comparing this split-dose regimen with standard cleansing the day before with sodium picosulphate/magnesium citrate.
Detailed Description
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Several split-dose bowel cleansing regimens have raised over the last decade aiming to substitute standard preparation the day before. These split-dose regimens (based on sodium phosphate and polyethylene glycol solutions) have demonstrated better cleansing scores, so it is probably more important the time that preparation is given rather than the type of solution. However, the time to administer the second half of the solution in split-dose regimens for morning colonoscopies remains controversial. A major concern of split-dose regimens is the risk of aspiration pneumonia during sedation if liquids have been administered quite close to the procedure. As such, the second part of the preparation is usually given early in the morning (2-3 am) in order to have a safety-period of at least four hours prior to the colonoscopy. However, this is quite disturbing for patients and may hamper the adherence to further colonoscopies. Furthermore, On the other hand, no study addressing the role of split-dose Citrafleet has been published to date
Therefore it is necessary to make a controlled clinical trial to directly compare "the day before" and " split-dose" regimens with Citrafleet for morning colonoscopies. In order to maximize the efficacy of the split-dose regimens, the time period between fluids intake and the colonoscopy will be shortened up up to 2 hours for morning colonoscopies scheduled from 9 to 11 am and up to 3 hours for that scheduled after 11 am. The results of this study will conclude whether there is still room for improvement in bowel cleansing for morning colonoscopies, using more palatable low-volume solutions without interrupting sleep time.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Sodium Picosulphate preparation the day before
Preparation the day before of the procedure using sodium picosulphate:
* A sachet mixed with 250 mL of water at 18:00 pm
* A sachet mixed with 250 mL of water at 21:00 pm
* A minimum of 4 litres of fluid were recommended throughout the preparation
Sodium picosulphate, magnesium oxid and citric acid
* A sachet mixed with 250 mL of water at 18:00 pm
* A sachet mixed with 250 mL of water at 21:00 pm
* A minimum of 4 litres of fluid were recommended throughout the preparation
Split-dose sodium picosulphate preparation
The day before the procedure:
\- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids
The day of the procedure:
* A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am.
* A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.
Sodium picosulphate/magnesium oxide and citric acid
The day before the procedure:
\- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids
The day of the procedure:
* A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am.
* A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.
Interventions
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Sodium picosulphate, magnesium oxid and citric acid
* A sachet mixed with 250 mL of water at 18:00 pm
* A sachet mixed with 250 mL of water at 21:00 pm
* A minimum of 4 litres of fluid were recommended throughout the preparation
Sodium picosulphate/magnesium oxide and citric acid
The day before the procedure:
\- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids
The day of the procedure:
* A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am.
* A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* age less than 18 years
* significant gastroparesis or gastric outlet obstruction or ileus
* known or suspected bowel obstruction or perforation
* phenylketonuria or glucose-6-phosphate dehydrogenase deficiency
* severe chronic renal failure (creatinine clearance \< 30 mL/minute)
* severe congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
* dehydration
* severe acute inflammatory disease
* compromised swallowing reflex or mental status
* uncontrolled hypertension (systolic blood pressure \> 170 mm Hg ad/or diastolic blood pressure \> 100 mm Hg)
* toxic colitis
* megacolon
18 Years
ALL
No
Sponsors
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Infante, Javier Molina, M.D.
INDIV
Responsible Party
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Principal Investigators
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Javier Molina-Infante, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital San Pedro de Alcantara, Caceres, Spain
Locations
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Hospital San Pedro de Alcantara
Cáceres, Caceres, Spain
Countries
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Central Contacts
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Facility Contacts
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Javier Molina-Infante, MD
Role: primary
References
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Hoy SM, Scott LJ, Wagstaff AJ. Sodium picosulfate/magnesium citrate: a review of its use as a colorectal cleanser. Drugs. 2009;69(1):123-36. doi: 10.2165/00003495-200969010-00009.
Love J, Bernard EJ, Cockeram A, Cohen L, Fishman M, Gray J, Morgan D. A multicentre, observational study of sodium picosulfate and magnesium citrate as a precolonoscopy bowel preparation. Can J Gastroenterol. 2009 Oct;23(10):706-10. doi: 10.1155/2009/385619.
Turner D, Benchimol EI, Dunn H, Griffiths AM, Frost K, Scaini V, Avolio J, Ling SC. Pico-Salax versus polyethylene glycol for bowel cleanout before colonoscopy in children: a randomized controlled trial. Endoscopy. 2009 Dec;41(12):1038-45. doi: 10.1055/s-0029-1215333. Epub 2009 Dec 4.
Hookey LC, Vanner SJ. Pico-salax plus two-day bisacodyl is superior to pico-salax alone or oral sodium phosphate for colon cleansing before colonoscopy. Am J Gastroenterol. 2009 Mar;104(3):703-9. doi: 10.1038/ajg.2008.167. Epub 2009 Feb 17.
Worthington J, Thyssen M, Chapman G, Chapman R, Geraint M. A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy. Curr Med Res Opin. 2008 Feb;24(2):481-8. doi: 10.1185/030079908x260844.
Renaut AJ, Raniga S, Frizelle FA, Perry RE, Guilford L. A randomized controlled trial comparing the efficacy and acceptability of phospo-soda buffered saline (Fleet) with sodium picosulphate/magnesium citrate (Picoprep) in the preparation of patients for colonoscopy. Colorectal Dis. 2008 Jun;10(5):503-5. doi: 10.1111/j.1463-1318.2007.01383.x. Epub 2007 Sep 13.
Park SS, Sinn DH, Kim YH, Lim YJ, Sun Y, Lee JH, Kim JY, Chang DK, Son HJ, Rhee PL, Rhee JC, Kim JJ. Efficacy and tolerability of split-dose magnesium citrate: low-volume (2 liters) polyethylene glycol vs. single- or split-dose polyethylene glycol bowel preparation for morning colonoscopy. Am J Gastroenterol. 2010 Jun;105(6):1319-26. doi: 10.1038/ajg.2010.79. Epub 2010 May 18.
Matro R, Shnitser A, Spodik M, Daskalakis C, Katz L, Murtha A, Kastenberg D. Efficacy of morning-only compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy: a randomized controlled single-blind study. Am J Gastroenterol. 2010 Sep;105(9):1954-61. doi: 10.1038/ajg.2010.160. Epub 2010 Apr 20.
Seo EH, Kim TO, Kim TG, Joo HR, Park MJ, Park J, Park SH, Yang SY, Moon YS. Efficacy and tolerability of split-dose PEG compared with split-dose aqueous sodium phosphate for outpatient colonoscopy: a randomized, controlled trial. Dig Dis Sci. 2011 Oct;56(10):2963-71. doi: 10.1007/s10620-011-1772-1. Epub 2011 Jun 9.
Kilgore TW, Abdinoor AA, Szary NM, Schowengerdt SW, Yust JB, Choudhary A, Matteson ML, Puli SR, Marshall JB, Bechtold ML. Bowel preparation with split-dose polyethylene glycol before colonoscopy: a meta-analysis of randomized controlled trials. Gastrointest Endosc. 2011 Jun;73(6):1240-5. doi: 10.1016/j.gie.2011.02.007.
Huffman M, Unger RZ, Thatikonda C, Amstutz S, Rex DK. Split-dose bowel preparation for colonoscopy and residual gastric fluid volume: an observational study. Gastrointest Endosc. 2010 Sep;72(3):516-22. doi: 10.1016/j.gie.2010.03.1125. Epub 2010 Jun 19.
Di Palma JA, Rodriguez R, McGowan J, Cleveland Mv. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009 Sep;104(9):2275-84. doi: 10.1038/ajg.2009.389. Epub 2009 Jul 7.
Gupta T, Mandot A, Desai D, Abraham P, Joshi A, Shah S. Comparison of two schedules (previous evening versus same morning) of bowel preparation for colonoscopy. Endoscopy. 2007 Aug;39(8):706-9. doi: 10.1055/s-2007-966375.
Longcroft-Wheaton G, Bhandari P. Same-day bowel cleansing regimen is superior to a split-dose regimen over 2 days for afternoon colonoscopy: results from a large prospective series. J Clin Gastroenterol. 2012 Jan;46(1):57-61. doi: 10.1097/MCG.0b013e318233a986.
Other Identifiers
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CITRA-SPLIT
Identifier Type: -
Identifier Source: org_study_id