NCT04702646|Completed
Patient and Colonoscopy Cleansing Quality Agreement
CALPER
Agreement Between Cleansing Quality Assessment During Colonoscopy and Patient Reported Cleansing Quality
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CALPER
Agreement Between Cleansing Quality Assessment During Colonoscopy and Patient Reported Cleansing Quality
Sponsor study identifier
observational
1,011
1 country
1
Study Start
February 17, 2021
Actual (reported)Primary Completion
May 31, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)The main purpose of the study is to determine the agreement between colon cleansing quality assessed by a validated scale (Boston Bowel Preparation Scale, BBPS) and the perception of the patient. Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS). The secondary aim is to assess predictors of poor bowel cleansing.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2021
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.
January 7, 2021
Actual (reported)January 11, 2021
Actual (reported)February 17, 2021
Actual (reported)May 31, 2021
Actual (reported)September 30, 2021
Actual (reported)Quality of bowel cleansing
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
[Time frame: 1 years][Designated as safety issue: No]
Predictive factors associated to an adequate bowel cleansing
[Time Frame: 1 years][Designated as safety issue: No]
Test the correlation between 3 sets of pictures and the cleansing quality following the Boston Bowel Preparation Scale
[Time Frame: 6 months][Designated as safety issue: No]
The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria
one day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylene glycol solution, 2 Liters of PEG-Ascorbic acid or 2 Liters Picosulfate.
colonoscopy will be performed to every patient included in the study
The researchers will offer to participate in the study to patients 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.
Department of Gastroenterology
San Cristóbal de La Laguna, S/C de Tenerife, 38320, Spain
Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.
Harewood GC, Wright CA, Baron TH. Assessment of patients' perceptions of bowel preparation quality at colonoscopy. Am J Gastroenterol. 2004 May;99(5):839-43. doi: 10.1111/j.1572-0241.2004.04176.x.
Antonio Z Gimeno Garcia, MD, PhD
Hospital Universitario de Canarias
1,011 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2021
First Posted
January 11, 2021
Study Start
February 17, 2021
Actual (reported)Artificial Intelligence and Bowel Cleansing Quality
Mucosa Adherent Intestinal Microbiome in Microscopic Colitis and Colorectal Cancer
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.
ASGE Technology Committee; Mamula P, Adler DG, Conway JD, Diehl DL, Farraye FA, Kantsevoy SV, Kaul V, Kethu SR, Kwon RS, Rodriguez SA, Tierney WM. Colonoscopy preparation. Gastrointest Endosc. 2009 Jun;69(7):1201-9. doi: 10.1016/j.gie.2009.01.035. No abstract available.
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, Pellise 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.
Hassan C, Fuccio L, Bruno M, Pagano N, Spada C, Carrara S, Giordanino C, Rondonotti E, Curcio G, Dulbecco P, Fabbri C, Della Casa D, Maiero S, Simone A, Iacopini F, Feliciangeli G, Manes G, Rinaldi A, Zullo A, Rogai F, Repici A. A predictive model identifies patients most likely to have inadequate bowel preparation for colonoscopy. Clin Gastroenterol Hepatol. 2012 May;10(5):501-6. doi: 10.1016/j.cgh.2011.12.037. Epub 2012 Jan 10.
Hernandez G, Gimeno-Garcia AZ, Quintero E. Strategies to Improve Inadequate Bowel Preparation for Colonoscopy. Front Med (Lausanne). 2019 Nov 8;6:245. doi: 10.3389/fmed.2019.00245. eCollection 2019.
Primary Completion
May 31, 2021
Actual (reported)Study Completion
September 30, 2021
Actual (reported)Last Updated
September 21, 2022
Record last verified: 2022-09
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Source: ClinicalTrials.gov.
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