NCT05871801|Completed
Predictive Models of Inadequate Colonic Preparation
Quality
Comparative Study of Predictive Models of Inadequate Colonic Preparation
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Quality
Comparative Study of Predictive Models of Inadequate Colonic Preparation
Sponsor study identifier
observational
600
1 country
1
Study Start
May 20, 2023
Actual (reported)Primary Completion
August 20, 2023
Actual (reported)Study Completion
September 1, 2023
Actual (reported)The main purpose of the study is to evaluate in a prospective cohort of patients with an appointment for the performance of an outpatient colonoscopy the prediction of the quality of colonic cleansing through the use of 3 predictive models. The colon cleansing quality will be assessed by a validated scale (Boston Bowel Preparation Scale, BBPS). Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2023
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.
May 13, 2023
Actual (reported)May 20, 2023
Actual (reported)May 23, 2023
Actual (reported)August 20, 2023
Actual (reported)September 1, 2023
Actual (reported)Rate of poor bowel cleansing assessed by the Boston Bowel Preparation Scale
Quality of bowel cleansing assessed by the 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). The maximum score is 9 points
3 months
Number of predictive factors of poor bowel cleansing
3 months
one day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylenglycol (PEG) solution, 2 Liters of PEG-Asccorbic acid or 2L sodium picosulphate.
Colonoscopy will be performed to every patient included in the study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The researchers will offer to participate in the study to outpatients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information.
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Dik VK, Moons LM, Huyuk M, van der Schaar P, de Vos Tot Nederveen Cappel WH, Ter Borg PC, Meijssen MA, Ouwendijk RJ, Le Fevre DM, Stouten M, van der Galien O, Hiemstra TJ, Monkelbaan JF, van Oijen MG, Siersema PD; Colonoscopy Quality Initiative. Predicting inadequate bowel preparation for colonoscopy in participants receiving split-dose bowel preparation: development and validation of a prediction score. Gastrointest Endosc. 2015 Mar;81(3):665-72. doi: 10.1016/j.gie.2014.09.066. Epub 2015 Jan 17.
Berger A, Cesbron-Metivier E, Bertrais S, Olivier A, Becq A, Boursier J, Lannes A, Luet D, Pateu E, Dib N, Caroli-Bosc FX, Vitellius C, Cales P. A predictive score of inadequate bowel preparation based on a self-administered questionnaire: PREPA-CO. Clin Res Hepatol Gastroenterol. 2021 Jul;45(4):101693. doi: 10.1016/j.clinre.2021.101693. Epub 2021 Apr 20.
Antonio Z Gimeno García, MD, PhD
Hospital Universitario de Canarias
600 participants (actual enrollment reported by the registry).
First Submitted
May 13, 2023
First Posted
May 23, 2023
Study Start
May 20, 2023
Actual (reported)Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)
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.
Primary Completion
August 20, 2023
Actual (reported)Study Completion
September 1, 2023
Actual (reported)Last Updated
August 13, 2024
Record last verified: 2024-08
Data will no be available to other researchers
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Source: ClinicalTrials.gov.
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