NCT03247452|Completed
Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)
DIETPREP
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DIETPREP
Sponsor study identifier
interventional
404
1 country
1
Study Start
December 18, 2017
Actual (reported)Primary Completion
March 31, 2018
Actual (reported)Study Completion
July 1, 2018
Actual (reported)This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet. Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2017
Actual (reported)August 11, 2017
Actual (reported)December 18, 2017
Actual (reported)March 31, 2018
Actual (reported)July 1, 2018
Actual (reported)Boston Bowel Preparation Scale
This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points
7 months
Proportion of polyps detected in each arm
7 months
Degree of satisfaction with diet
7 months
Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered
Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered
One-day low fiber diet before colonoscopy
Three days low fiber diet before colonoscopy
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Polyethylene Glycol plus ascorbic acid
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordDepartment of Gastroenterology
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
Enrique Quintero, MD, PhD
Hospital Universitario de Canarias
404 participants (actual enrollment reported by the registry).
First Submitted
August 9, 2017
First Posted
August 11, 2017
Study Start
December 18, 2017
Actual (reported)Predictive Models of Inadequate Colonic Preparation
2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.
Gimeno-Garcia AZ, de la Barreda Heuser R, Reygosa C, Hernandez A, Mascareno I, Nicolas-Perez D, Jimenez A, Lara AJ, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez G, Hernandez D, Delgado R, Quintero E. Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial. Endoscopy. 2019 Jul;51(7):628-636. doi: 10.1055/a-0864-1942. Epub 2019 Apr 3.
Primary Completion
March 31, 2018
Actual (reported)Study Completion
July 1, 2018
Actual (reported)Last Updated
August 15, 2018
Record last verified: 2018-08
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Source: ClinicalTrials.gov.
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